Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Recurrence

Lymphoma

Leukemia

Leukemia, Lymphoid

Lymphoma, Non-Hodgkin

Leukemia, Lymphocytic, Chronic, B-Cell

Hodgkin Disease

Leukemia, Prolymphocytic

Leukemia, Prolymphocytic, T-Cell

Disease Progression

Waldenstrom Macroglobulinemia

Leukemia, Plasma Cell

Leukemia, Prolymphocytic, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Disease Attributes

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Leukemia, B-Cell

Chronic Disease

Leukemia, T-Cell

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Hodgkin Lymphoma

T-cell Prolymphocytic Leukemia

Plasma Cell Leukemia

B Cell Prolymphocytic Leukemia

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Antirheumatic Agents

Dermatologic Agents

Amino Acids

Etoposide

Cytarabine

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Melphalan

Mycophenolic Acid

Tacrolimus

Etoposide phosphate

Podophyllotoxin

Carmustine

Mechlorethamine

Nitrogen Mustard Compounds

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Enzyme Inhibitors

Antiviral Agents

Calcineurin Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Keratolytic Agents

Tubulin Modulators

Antimitotic Agents

Phenylalanine

Alanine

Allogeneic Bone Marrow Transplantation

Allogeneic Hematopoietic Stem Cell Transplantation

Autologous Hematopoietic Stem Cell Transplantation

Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation

Fludarabine Phosphate

Laboratory Biomarker Analysis

Mycophenolate Mofetil

Peripheral Blood Stem Cell Transplantation

Total-Body Irradiation

Mohamed Sorror

This phase II trial studies autologous peripheral blood stem cell transplant followed by donor bone marrow transplant in treating patients with high-risk Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, or chronic lymphocytic leukemia. Autologous stem cell transplantation uses the patient's stem cells and does not cause graft versus host disease (GVHD) and has a very low risk of death, while minimizing the number of cancer cells. Peripheral blood stem cell (PBSC) transplant uses stem cells from the patient or a donor and may be able to replace immune cells that were destroyed by chemotherapy. These donated stem cells may help destroy cancer cells. Bone marrow transplant known as a nonmyeloablative transplant uses stem cells from a haploidentical family donor. Autologous peripheral blood stem cell transplant followed by donor bone marrow transplant may work better in treating patients with high-risk Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, or chronic lymphocytic leukemia.

PRIMARY OBJECTIVES:

I. Event-free survival (EFS) at 1-year after autograft.

SECONDARY OBJECTIVES:

I. Relapse rates at 1-year after autograft.

II. Overall survival (OS) at 1-year after autograft.

III. Incidence of grades II-IV acute GVHD and chronic extensive GVHD.

IV. Non-relapse mortality (NRM) at 200 days and 1 year after allograft.

V. Donor engraftment at day +84.

VI. Incidence of infections.

OUTLINE:

CONDITIONING REGIMEN 1 (lymphoma, Waldenstrom macroglobulinemia, or chronic lymphocytic leukemia \[CLL\] with no dose limiting radiation or significant comorbidities: Patients receive cyclophosphamide intravenously (IV) on days -6 and -5. Patients undergo high-dose total body irradiation (TBI) twice daily (BID) on days -3 to -1.

CONDITIONING REGIMEN 2 (lymphoma, Waldenstrom Macroglobulinemia, CLL, with prior dose-limiting radiation, or significant comorbidities): Patients receive carmustine IV on day -7, etoposide IV BID on days -6 to -3, cytarabine IV BID on days -6 to -3, and melphalan IV on day -2.

CONDITIONING REGIMEN 3 (multiple myeloma or plasma cell leukemia, with no significant renal insufficiency or other significant comorbidities): Patients receive high-dose melphalan IV on day -2.

CONDITIONING REGIMEN 4 (multiple myeloma or plasma cell leukemia, with significant renal insufficiency or other significant comorbidities): Patients receive lessened dose of melphalan IV on day -2.

PBSC TRANSPLANTATION: All patients undergo autologous PBSC transplantation on day 0.

WAITING INTERVAL: Between 40 and 120 days.

NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV once daily (QD) on days -6 to -2 and cyclophosphamide IV QD on days -6 to -5 and day 3. Patients infused with donor's peripheral blood stem cells will additionally receive cyclophosphamide IV on day 4. Patients undergo low-dose TBI on day -1.

ALLOGENEIC BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0.

GRAFT VERSUS HOST DISEASE PROPHYLAXIS: Beginning on day 4, patients receive tacrolimus orally (PO) or IV and taper beginning on day 86 if no graft-versus-host disease. Patients also receive mycophenolate mofetil PO thrice daily (TID) on days 4 - 35.

PERIPHERAL BLOOD COUNT SUPPORT: Patients receive filgrastim (G-CSF) IV or subcutaneously (SC) beginning from day 4 and continue till blood counts recover.

ALLOGENEIC PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC) TRANSPLANTATION: Patients undergo donor PBMC transplantation on day 0.

GRAFT VERSUS HOST DISEASE PROPHYLAXIS: Beginning on day 5, patients receive tacrolimus orally (PO) or IV and taper beginning on day 86 if no graft-versus-host disease. Patients also receive mycophenolate mofetil PO thrice daily (TID) on days 5 - 35.

PERIPHERAL BLOOD COUNT SUPPORT: Patients receive filgrastim IV or SC beginning from day 5 and continue till blood counts recover.

After completion of study treatment, patients are followed up annually for 5 years.

Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia

Sequential Autologous HCT / Nonmyeloablative Allogeneic HCT Using Related, HLA-Haploidentical Donors for Patients With High-Risk Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia

Number of patients surviving without relapsed/progressive disease

Relapse/Progression defined as:

Nodes, liver, and/or spleen ≥50% increased or new by physical exam / imaging studies.

Circulating lymphocytes ≥50% increased by morphology and/or flow cytometry. Richter's transformation by lymph node biopsy .

Number of patients surviving one year post-autograft

aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999).

GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.

Number of patients with non-relapse mortalities.

Number of patients with donor engraftment.

National Cancer Institute (NCI)

Fred Hutchinson Cancer Center

Allogeneic Bone Marrow Transplantation: Undergo donor HCT

Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT

Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant

Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT

Carmustine: Given IV

Cyclophosphamide: Given IV

Cytarabine: Given IV

Etoposide: Given IV

Fludarabine Phosphate: Given IV

Laboratory Biomarker Analysis: Correlative study

Melphalan: Given IV

Mycophenolate Mofetil: Given PO

Peripheral Blood Stem Cell Transplantation: Undergo donor HCT

Tacrolimus: Given IV or PO

Total-Body Irradiation: Undergo TBI

Treatment (Autologous HCT, Donor HCT)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Mohamed L. Sorror

Event-Free Survival (EFS)

Number of Patients With Relapsed/Progressive Disease

Overall Survival

Acute Graft-versus-Host-Disease

Chronic extensive Graft-versus-Host-Disease

Two patients are not evaluable for Graft-versus-Host-Disease due to disease progression; they failed the study and did not receive the allogeneic transplantation.

Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease

200 days

1 Year

Two patients are not evaluable for GVHD due to disease progression; they failed the study and did not receive the allogeneic transplantation.

Non-relapse Mortality (NRM)

Number of Patients Who Engrafted

Number of Patients Who Had Infections

Overall Study

Plasmacytoma

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Lenograstim

Lenalidomide

Bortezomib

Dexamethasone acetate

Ixazomib

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Fludarabine+Melphalan followed by Allogeneic SCT.

Consolidated Chemotherapy for Patients Unable to Receive Transplantation

Allogeneic Stem Cell Transplant: Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with GCSF mobilization and infused fresh to the recipients.

Autologous hematopoietic stem cell transplantation :Stem cell mobilization with granulocyte colony-stimulating factor (GCSF) at a dose of 10 μg/kg/day followed collecting CD34+ peripheral blood stem cells . Day 0 Infusion of autologous stem cells. Patients during 3-6 months after the 1st SCT will undergo a 2nd SCT. Patients who had not enough PBSC will undergo a 1st SCT.

Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2

conditioning regimen: autologous ARM: Day -2 Melphalan 200 mg/m\^2/day IV over 30 minutes. allogeneic ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes

Melphalan Given IV

conditioning regimen:Days -6,-5,-4,-3 Fludarabine 30 mg/m\^2/day IV

Fludarabine Injection

Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)

PI and dexamethasone as maintenance therapy

Oral lenalidomide at the starting dose of 25mg on days 1-21 every 28 days or days 1-14 every 21 days. Dexamethasone at 20mg twice weekly on days 1,2,4,5,8,9,11\&12 of each 21-day.

PI+IMids+Dexamethasone as Consolidated Chemotherapy

WEI W SUI, Dr.

GANG AN, Dr.

WEI W SUI, Master

Lu G Qiu, Dr.

The clinical trial was conducted in a cohort of young, high-risk myeloma patients who were designed to receive a combination of high-dose chemotherapy with allogeneic or autologous hematopoietic stem cell transplantation. The objective was to assess the progression free survival (PFS), overall survival (OS),and overall response rate (ORR) of the overall treatment.

50 cases of HR-NDMM patients were divided into two groups nonrandomizedly. TE group received hematopoietic stem cell transplantation after induction therapy. Allo-sct for the young patients with suitable donors, Asct for the others. TNE group received consolidation therapy after induction therapy. All patients received PI-based maintenance therapy.

a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients

Phase II Open Lable Clinical Study Efficacy and Safety of the Holistic Treatment for Young Patients With High-Risk Multiple Myeloma

PFS is defined as the duration from the data of registration to either progressive disease or death, whichever comes first.

ORR is defined as the proportion of subjects who achieve PR to better rate, according to the IMWG criteria

OS is defined as the duration from the data of registration to death.If the subject is alive, the data will be censored as being alive; the vital status is unknown as last known.

aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999).

GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death cGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.

Number of patients with non-relapse mortalities

Institute of Hematology & Blood Diseases Hospital, China

Chief physician

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia	NCT01008462	B-Cell Prolymph... Hypodiploidy Loss of Chromos... Plasma Cell Leu... Progression of ... Recurrent Adult... Recurrent Adult... Recurrent Child... Recurrent Child... Recurrent Chron... Recurrent Plasm... Recurrent Small... Refractory Chil... Refractory Chro... Refractory Non-... Refractory Plas... Refractory Smal... t(14;16) t(4;14) T-Cell Prolymph... Waldenstrom Mac...	Allogeneic Bone... Allogeneic Hema... Autologous Hema... Autologous-Allo... Carmustine Cyclophosphamid... Cytarabine Etoposide Fludarabine Pho... Laboratory Biom... Melphalan Mycophenolate M... Peripheral Bloo... Tacrolimus Total-Body Irra...	- 75 Years	Fred Hutchinson Cancer Center
a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients	NCT04008888	Multiple Myelom... Plasma Cell Leu... Extramedullary ... Loss of Chromos... t(14;16) t(4;14) T(14;20) 1Q21 Amplificat... Complex Karyoty...	Allogeneic Hema... Autologous Hema... Melphalan Given... Fludarabine Inj... PI and dexameth... PI+IMids+Dexame...	18 Years - 60 Years	Institute of Hematology & Blood Diseases Hospital, China

Spots Global Cancer Trial Database for t(14;16)

Every month we try and update this database with for t(14;16) cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for t(14;16)

Every month we try and update this database with for t(14;16) cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for t(14;16) cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.