Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Etoposide

Gemcitabine

Vinorelbine

Cyclophosphamide

Etoposide phosphate

Carmustine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Gemcitabine and high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue. Chemotherapy includes Gemcitabine + Vinorelbine + Carmustine + Etoposide + Cyclophosphamide.

Autologous HCT

Sally Arai, MD

This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue for Hodgkin's Disease

To assess the non-hematologic toxicity and determine the phase 2 dose of gemcitabine in combination with vinorelbine followed by carmustine, etoposide and cyclophosphamide and autologous hematopoietic stem cell transplantation \[aka peripheral blood stem cell (PBSC)\].

Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease

Gemcitabine and High-dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease

Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.

Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU).

Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).

Reports the percentage of participants that experienced relapse post-transplant.

Reports the survival measures:

* Freedom from progression (FFP)
* Event-free survival (EFS)
* Overall survival (OS)

EFS and OS were estimated by Kaplan-Meier method

Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

National Institutes of Health (NIH)

National Institute of Allergy and Infectious Diseases (NIAID)

Stanford University

Assistant Professor of Medicine

Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].

Gemcitabine + High-dose Chemotherapy + PBSC Rescue

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Sally Arai

1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue

1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue

7 patients received 1 of 2 dose levels during the Phase 1 dose-escalation component of the study

Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity

Gemcitabine (1250 or 1500 mg/m2) administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].

Patients who completed the study regardless of gemcitabine dose, and had all data points collected.

Pulmonary Toxicity (BCNU Pneumonitis)

Gemcitabine (1250 or 1500 mg/m2) as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].

Overall Survival (OS)

Relapse Post-transplant

Freedom from Progression (FFP)

Event-Free Survival (EFS)

Gemcitabine 1250 mg/m2 administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].

1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue

Lists the results as included in the publication, which included 92 participants who received the MTD treatment; completed the study; and had all data points collected

Survival Measures

1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue

Phase I Dose Escalation

Phase 2 Dose Expansion

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Cytarabine

Antiviral Agents

5.1.3. After achieving CR1, patient will be invited to this protocol and will be able to decide whether to join or not after listening to the information.

5.1.3.1. If he/she decides to participate, request of health insurance support on the autologous HCT will be submitted and further processes related to autologous HCT will continue.

If he/she decides not to participate, he/she will be treated with HDAC consolidation chemotherapy, which is the current standard treatment.

HDAC chemotherapy

After achieving CR1, patient will be invited to this protocol and will be able to decide whether to join or not after listening to the information.

If he/she decides to participate, request of health insurance support on the autologous HCT will be submitted and further processes related to autologous HCT will continue.

Dae-Young Kim, professor

Yae Eun Jang, nurse

Evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1).

5.2 AUTOLOGOUS PBSCS HARVESTING

5.2.1. PBSCs will be collected during recovery phase after the second cycle of HDAC consolidation chemotherapy.

5.2.2. For mobilization, recombinant human granulocyte- colony-stimulating factor (G-CSF, Filgrastim) will be given subcutaneously at a dose of 10 mcg/kg from day 9 of the 2nd HDAC cycle until the completion of harvesting.

5.2.3. PBSCs harvesting will be performed via perm-cath or Quinton catheter, which will be inserted with fluoroscopy-guided before starting and will be removed after finishing harvest.

5.2.4. Harvest will be initiated from the day when the peripheral absolute neutrophil count reach up to 0.2 x 109/mm3. Peripheral blood mononuclear cells will be collected by leukapheresis method with 'CS-3000' (Baxter, Deerfield, IL) or other compatible machine. Cell collection will be performed for at least 2 days and the duration of collection can be extended until a target CD34+ cell dose of 5 x 106/kg (in terms of body weight of recipient) is collected.

5.2.5. If adequate numbers of CD34+ cells are not collected, the 3rd HDAC chemotherapy will be done and mobilization/harvest procedure will be repeated.

5.2.6. Stem cells harvested from patient will be frozen in liquid nitrogen tank for future autologous HCT cell infusion.

5.3.PRETRANSPLANT WORKUP FOR AUTOLOGOUS HCT 5.3.1. Pre-workup for checking the current disease status and feasibility for autologous HCT will be performed before the conditioning and infusion of autologous HCT.

5.3.2. It is recommended that baseline workup for hematologic / non-hematologic status will be performed at least 1 month prior to the initiation of conditioning. Bone marrow aspirate/ biopsy with cytogenetics and diagnostic lumbar puncture can be performed immediately before the initiation of conditioning.

5.3.3. Pretransplant workup tests are listed in Appendix IV.

5.4. CONDITIONING REGIMEN FOR AUTOLOGOUS HCT 5.4.1. On admission, 5.4.1.1.Menstruating women will be given norethindrone (Norlutate) 10mg po daily until platelet count is consistently over 100,000 /mcL.

5.4.1.2.Actual body weight (ABW) for busulfan will be calculated using following guidelines; 5.4.1.2.1.If ABW is less or equal to ideal body weight (IBW), use ABW. 5.4.1.2.2.If ABW is greater than IBW but ABW is within 120% of IBW, use IBW. 5.4.1.2.3.If ABW is 120% or greater than IBW, use IBW+25% (ABW-IBW). 5.4.1.2.4.IBW(ideal body weight) will be calculated in 5.4.1.2.4.1.Male: 50 kg + 2.3kg (height\[inch\]-60) 5.4.1.2.4.2.Female: 45.5kg + 2.3kg (height\[inch\]-60) 5.4.1.2.4.3.1inch=2.54cm 5.4.2. On day -8, preparation drugs will be administered to patient as below; 5.4.2.1.Hydration with 0.9% normal saline will be started at 6PM and infused continuously at a rate of 100mL/hr through day -4.

5.4.2.2.Allopurinol 300mg/day will be taken p.o. once a day from day-8 to -2. 5.4.2.3.Heparin 100 U/kg/day in normal saline 500 mL will be infused continuously at a rate of 20mL/hr through day 20 (6pm). Heparin should be discontinued if there is clinically significant bleeding or aPTT level exceeds 1.2 time of the upper normal limit.

5.4.2.4.Dilantin 15mg/kg (ABW) in normal saline 300cc will be infused continuously at a rate of 200mL/hr at 8PM, and then, 200mg will be taken p.o. twice a day through day -4. Dilantin level should be monitored in the morning of day-7 and -6 to maintain the level within 10 to 20 mg/L.

5.4.3. From day-7, conditioning drug will be administered to patient as below; 5.4.3.1.Busulfan 3.2mg/kg/day in normal saline of 10 times the volume of busulfan will be infused continuously over 3 hours with an interval of 24 hours on days -7 to -5 (for 3 days).

5.4.3.2.Etoposide 200mg/m2/day in normal saline 1000mL will be infused continuously over 5 hours twice a day with an interval of 12 hours on day-3 to -2 (for 2 days).

5.4.3.3.Antiemetics such as serotonin antagonist or lorazepam are allowed.

5.5. AUTOLOGOUS PBSCS INFUSION 5.5.1. Autologous PBSCs will be infused on day0. 5.5.1.1.Premedication including pheniramine maleate (avil) 45.5mg i.v., acetaminophen 600mg p.o., hydrocortisone 250mg i.v. and furosemide 20mg i.v. will be given 30 minutes before cell infusion.

5.5.1.2.PBSCs will be infused via saline infusion set without in-line filters. 5.5.1.3.Vital sign should be checked 4 times with 15 minutes of interval, 4 times with 30 minutes, and then 4 times with 1 hour. Electrocardiogram monitoring will be performed from the start until the completion of PBSCs infusion.

5.5.1.4.Following medications should not be administered simultaneously with PBSCs; 5.5.1.4.1.Lipid-containing total parenteral nutrition fluid 5.5.1.4.2.Conventional or liposomal amphotericin 5.6. SUPPORTIVE CARE 5.6.1. Recombinant human G-CSF (rhG-CSF) 450㎍ in 100 mL of D5W will be infused intravenously over 30 minutes from day 5 till ANC\>3,000/㎕.

5.6.2. Ciprofloxacin 500mg will be given p.o. twice a day (for selective bowel decontamination) from day 1 till ANC\>3,000/㎕. With the first fever spike, ciprofloxacin can be replaced with broad spectrum antibiotics.

5.6.3. Micafungin 50mg will be infused intravenously once a day from day1 till ANC\>3,000/㎕.

5.6.4. Acyclovir 250mg/m2 will be infused twice a day from day1 till ANC\>3,000/㎕.

5.6.5. In case of oral mucositis, sodium bicarbonate/saline mouthwash will be applied four times a day until resolved.

5.6.6. Clotrimazole or Canesten® powder can be applied to groin, axilla, and perianal area twice a day from day-8 until engraftment.

5.6.7. All cellular blood products must be transfused after leukocyte filtration and irradiation.

5.6.8. For woman of childbearing potential, adequate consultation for ovarian protection can be sought. For man who intend to have child(ren) in future, sperm banking can be recommended and performed.

5.7. EVALUATION DURING TREATMENT 5.7.1. CBC with differential count, ALT/AST, bilirubin with BUN/Cr, and electrolyte will be checked once daily.

5.7.2. Chemical battery with BUN/phosphorus, LDH and level of magnesium will be checked three times a week.

5.7.3. Coagulation battery with fibrinogen/d-dimer will be checked at day 0, 7, 14, 21 and once a week thereafter until discharge.

5.7.4. Protein C, antithrombin III, t-PA antigen, and PAI-1 antigen will be checked at day 0, 7, 14, and 21.

5.7.5. Urinalysis will be checked once a week. 5.7.6. Chest X-ray will be checked once a week routinely and more frequently according to patient's condition.

5.7.7. Blood galactomannan (aspergillosis antigen, GM) assay can be recommended to be checked once a week until ANC\>3,000/ according to the physician's decision.

5.8. POST-HCT FOLLOW-UP INCLUDING MRD MONITORING 5.8.1. Patients will be followed with physical examination and appropriate blood test including CBC at least every 3 months for 3 years, every 6 months for the next 2 years, and then annually thereafter.

5.8.2. Toxicities related to treatment will be assessed and reported according to NCI CTCAE v3.0.

5.8.3. Minimal residual disease (MRD) monitoring with RQ-PCR for AML1/ETO or CBFβ/MYH11 will be performed before autologous HCT (bone marrow and peripheral blood, 1 month after autologous HCT (bone marrow and peripheral blood), and thereafter, every 3 months (peripheral blood only) until 3 years after autologous HCT.

5.8.4. If RQ-PCR is not available, RT-PCR and/or FISH can be used for MRD monitoring

Autologous Hematopoietic Cell Transplantation for Core-binding Factor (CBF) Acute Myeloid Leukemia (AML) in the First Complete Remission (CR1)

Autologous Hematopoietic Cell Transplantation for Core-binding Factor Positive Acute Myeloid Leukemia in the First Complete Remission

* Relapse incidence (cumulative incidence of relapse, CIR)
* Disease-free survival (DFS)

* Engraftment rate / time to engraftment
* Transplantation-related mortality (TRM)
* Event-free survival (EFS)
* Overall survival (OS)

Cooperative Study Group A for Hematology

COSAH

Antibodies

Antibodies, Monoclonal

Molgramostim

Sargramostim

Daunorubicin

Immunoglobulins

Busulfan

Gemtuzumab

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.

Consolidation/Transplant:

Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.

The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.

Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.

Consolidation/Transplant:

Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.

The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.

Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.

Consolidation/Transplant:

Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.

The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.

Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.

Consolidation/Transplant:

Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.

The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.

Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.

Consolidation/Transplant:

Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count \> 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available.

Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.

Consolidation/Transplant:

Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count \> 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available.

sargramostim

busulfan

cyclophosphamide

cytarabine

gemtuzumab ozogamicin (GO)

Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.

Autologous hematopoietic cell transplantation

Allogeneic hematopoietic cell transplantation

Allogeneic HCT

Hugo F. Fernandez, MD

RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia.

PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.

OBJECTIVES:

* To compare the overall survival (OS) between two induction regimens (standard versus dose intense daunorubicin and cytarabine) in patients with de novo AML.
* To compare disease-free survival (DFS) between two consolidation regimens.
* To compare overall survival between two consolidation regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to induction therapy (standard-dose daunorubicin vs high-dose daunorubicin).

* Induction therapy: Patients are randomized to 1 of 2 induction arms.

  * Standard: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7.
  * High dose: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I.

Patients in both arms may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. The second course is administered as in arm I to all patients. Patients who don't achieve CR after 2 courses of induction therapy are removed from study.

Patients who achieve CR after induction therapy proceed to post-remission therapy with EITHER allogeneic transplantation only (on or off study) OR consolidation therapy and autologous transplantation (on study), according to risk status and donor status.

Patients who are considered at intermediate or high risk for relapse (unfavorable cytogenetics/high WBC) and have a suitable related donor undergo an allogeneic transplantation. Patients with intermediate-risk cytogenetics, WBC no greater than 100,000/mm\^3, and appropriate donors have the option of undergoing allogeneic transplantation.

* Allogeneic transplantation: Within 1-3 months after recovery from induction therapy, patients receive busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 4 hours on days -3 and -2. Allogeneic bone marrow or peripheral blood stem cells (PBSCs) are infused on day 0. Patients receive graft-vs-host disease (GVHD) prophylaxis comprising cyclosporine IV over 1-4 hours beginning on day -1 and then orally (when tolerated) twice daily until day 180. Alternatively, patients may receive tacrolimus IV over 24 hours beginning on day -1 and then orally twice daily until day 180. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

Patients who do not meet the criteria for allogeneic transplantation (i.e., are favorable risk or do not have a matching related donor) or who opt not to undergo allogeneic transplantation proceed to consolidation therapy followed by randomization to 1 of 2 autologous transplantation arms.

* Consolidation therapy: Beginning 2-8 weeks after recovery from induction therapy, patients receive high-dose cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. A second course is administered 3 weeks after blood recovery. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 4 days and then autologous PBSCs are harvested by leukapheresis.
* Autologous stem cell transplantation: Patients are randomized to 1 of 2 autologous transplantation arms.

  * Arm I: Within 1 month after PBSC collection, patients receive conditioning comprising busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo autologous PBSC transplantation on day 0. Patients receive sargramostim (GM-CSF) or G-CSF IV or SC beginning on day 0 and continuing until blood counts recover.
  * Arm II (closed to accrual as of 10/4/2007): Within 2-4 weeks after PBSC collection, patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and GM-CSF SC or IV beginning on day 10 and continuing until blood counts recover. Within 2-3 weeks after blood count recovery, patients receive conditioning and undergo autologous PBSC transplantation as in arm I.

Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months for up to 7 years.

ACTUAL ACCRUAL: A total of 657 patients were accrued for this study.

Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia

A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation

Overall survival is defined as the time from randomization in the induction phase to death.

Disease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease.

Overall survival is defined as the time from randomization in the consolidation phase to death.

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.

Conditioning/Transplant:

Patients receive conditioning comprising busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo autologous peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive sargramostim (GM-CSF) or filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 0 and continuing until blood counts recover.

Standard Daunorubicin (Induction Therapy)

Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.

Conditioning/Transplant:

Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and GM-CSF SC or IV beginning on day 10 and continuing until blood counts recover. Within 2-3 weeks after blood count recovery, patients receive conditioning and undergo autologous PBSC transplantation as in arm I.

High Dose Daunorubicin (Induction Therapy)

Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7.

Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.

Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.

Total

Age, Continuous

Statistician

Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.

Standard Daunorubicin

Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.

High-dose Daunorubicin

All randomized patients are included in the analysis (intention-to-treat).

Overall Survival (Induction Phase)

Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.

Go/Autologous HCT

Only 270 patients who were randomized in the consolidation phase are included in the analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease	NCT00388349	Hodgkin Disease Hodgkin's Lymph... Lymphoma	Gemcitabine Vinorelbine Carmustine Etoposide Cyclophosphamid... Autologous HCT	18 Years - 70 Years	Stanford University
Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease	NCT00388349	Hodgkin Disease Hodgkin's Lymph... Lymphoma	Gemcitabine Vinorelbine Carmustine Etoposide Cyclophosphamid... Autologous HCT	18 Years - 70 Years	Stanford University
Autologous Hematopoietic Cell Transplantation for Core-binding Factor (CBF) Acute Myeloid Leukemia (AML) in the First Complete Remission (CR1)	NCT01146977	Acute Myeloid L...	HDAC chemothera... Autologous HCT	15 Years - 65 Years	Cooperative Study Group A for Hematology
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia	NCT00049517	Leukemia	sargramostim busulfan cyclophosphamid... cytarabine gemtuzumab ozog... Daunorubicin Autologous HCT Allogeneic HCT	16 Years - 60 Years	Eastern Cooperative Oncology Group
Autologous Hematopoietic Cell Transplantation for Core-binding Factor (CBF) Acute Myeloid Leukemia (AML) in the First Complete Remission (CR1)	NCT01146977	Acute Myeloid L...	HDAC chemothera... Autologous HCT	15 Years - 65 Years	Cooperative Study Group A for Hematology

Spots Global Cancer Trial Database for autologous hct