Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Hodgkin Disease

Lymphoma, Non-Hodgkin

Lymphoma, Large B-Cell, Diffuse

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphoma, B-Cell

Chronic Graft Versus Host Disease

Lymphosarcoma

Peripheral T-cell Lymphoma

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Hodgkin Lymphoma

B-cell Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Anti-Infective Agents

Micronutrients

Hematinics

Vitamins

Tacrolimus

Etoposide

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Methotrexate

Sirolimus

Etoposide phosphate

Busulfan

Temsirolimus

MTOR Inhibitors

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Calcineurin Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Folinic Acid

Folate

Vitamin B9

All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.

Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.

Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD).

0.8 mg/kg intravenous (IV) bolus every six hours (Q6H) on days -8,-7,-6,-5 (total of 14 doses). The total daily dose of busulfan will be 3.2 mg/kg on days -8,-7, and -6 and 1.6 mg/kg on day -5

Busulfan (conditioning for AUTO transplant)

Etoposide 30 mg/kg IV bolus every day (QD) on day -4. The total daily dose of etoposide will be 30 mg/kg.

Etoposide (conditioning for AUTO transplant)

Cyclophosphamide 60 mg/kg IV bolus QD on days -3 and -2. The total daily dose of cyclophosphamide will be 60 mg/kg.

Cyclophosphamide (conditioning for AUTO transplant)

Mesna 15 mg/kg IV bolus on days -3 and -2 infused over 15 minutes and given 15 minutes prior to cyclophosphamide administration. This is followed by Mesna given 15 mg/kg IV bolus three times daily (TID) on days -3 and -2 infused over 15 minutes at 3, 6, and 9 hours after completion of cyclophosphamide infusion. Total daily dose of Mesna should be equivalent to daily dose of cyclophosphamide. Lastly, Mesna will be given at 15 mg/kg IV bolus QD on day -1. This makes a total of 9 doses of Mesna

Mesna (prior to AUTO transplant)

Infusion of autologous peripheral blood stem cells on Day 0.

autologous (auto) peripheral blood stem cell transplantation

Neupogen 5 mcg/kg subcutaneous (SQ) daily starting on day +1 until absolute neutrophil count (ANC) is greater than or equal to 1000 per micro liter on two separate occasions or greater than 5000 per micro liter once

Neupogen

Fludarabine 30 mg/m2/day will be administered as a bolus infusion over approximately 30 minutes for 4 days on days -5, -4, -3, -2.

Fludarabine (conditioning for ALLO Transplant)

Busulfan will be administered by IV infusion over approximately 3 hours on days -5, -4, -3, -2. The dose of busulfan will be 0.8 mg/kg/day

Busulfan (conditioning for ALLO Transplant)

Donor peripheral blood stem cells (PBSC) will be infused intravenously beginning on Day 0. The minimum total CD34+ cell dose will be 2 x 10\^6 CD34+cells/kg of recipient's actual body weight with a maximum dose of 8 x 10\^6/kg of recipient's actual body weight

non-myeloablative allogeneic (allo) transplant

Tacrolimus (FK506) will be given orally at a dose of 0.05 mg/kg orally (PO) twice a day (BID) starting day -3.

Sirolimus (rapamycin) will be given orally at a dose of 12 mg times one on day -3 and then the dose shall be 4 mg by mouth daily starting on day -2. The dose may then be adjusted according to serum levels at the discretion of the treating physician

Methotrexate will be administered once daily on days 1, 3, and 6 as an IV bolus over 15 minutes at a dose of 5 mg/m2

Yi-Bin A Chen, MD

Relapse remains a principle cause of treatment failure for patients with aggressive lymphoma after autologous transplantation. Non-myeloablative allogeneic transplantation allows patients to receive an infusion of donor cells in an attempt to induce a graft versus lymphoma effect. This study will assess the feasibility, safety and efficacy of the combination of autologous stem cell transplantation followed by non-myeloablative transplantation for patients with poor-risk aggressive lymphoma.

This is a phase II clinical trial investigating the feasibility, and efficacy of sequential autologous stem cell transplant followed by non-myeloablative allogeneic transplant for patients with poor risk lymphoma. Patients will be enrolled onto the trial when eligible and undergo standard high-dose chemotherapy with the combination with busulfan, cyclophosphamide, and etoposide followed by autologous stem cell transplant. After recovery of counts and clinical status, patients will then proceed to non-myeloablative allogeneic stem cell transplant using a fully matched related or unrelated donor.

Tandem Auto-Allo Transplant for Lymphoma

Sequential Myeloablative Autologous Stem Cell Transplantation Followed by Allogeneic Non-Myeloablative Stem Cell Transplantation for Patients With Poor Risk Lymphomas

Successful donor stem cell engraftment is defined as when ≥ 80% of hematopoietic elements are donor-derived as determined by chimerism assays from peripheral blood at day 100 after non-myeloablative allogeneic stem cell transplantation.

Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.

Extensive chronic graft versus-host-disease (GVHD) was defined as GVHD that required systemic immunosuppression.

Non-relapse mortality is defined as participants who die from causes other than their underlying disease relapse, such as infection or graft versus host disease

Dana-Farber Cancer Institute

Massachusetts General Hospital

Autologous Then Allogeneic Transplant

Autologous then allogeneic stem cell transplantation

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Prior lines of chemotherapy

Diagnosis

Disease status at study entry

Yi-Bin Chen, MD

Participants who underwent the full tandem AUTO-ALLO stem cell transplant

Peripheral Blood All-cell Donor Chimerism

This was only measured in the 17 participants who experienced a hematological nadir after allo transplant.

Number of Days After Allogeneic Transplant Until Absolute Neutrophil Count Was Equal to or Greater Than 500/uL

Cumulative Incidence of Grades II to IV Acute Graft Versus Host Disease (GVHD)

Cumulative Incidence of Extensive Chronic Graft-versus-host-disease

Cumulative Incidence of Non-relapse Mortality

Cumulative Incidence of Disease Relapse

Estimated Two Year Progression Free Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants

Estimated Two Year Overall Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants

Estimated Two Year Progression Free Survival Rate for All Participants

Estimated Two Year Overall Survival Rate for All Participants

Participants who ONLY underwent Autologous transplant (did not proceed to Allogeneic)

Estimated Two Year Progression Free Survival Rate for Participants Undergoing Only Autologous Transplant

Participants who ONLY underwent Autologous transplant, did not proceed to Allogeneic transplant

Estimated Two Year Overall Survival Rate for Participants Undergoing Only Autologous Transplant

Autologous, then Allogeneic Stem Cell Transplantation

Autologous Transplant

Evaluation for Allogeneic Transplant

Allogeneic Transplant

Spots Global Cancer Trial Database for Tandem Auto-Allo Transplant for Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial