Lymphoma Clinical Trial
Official title:
Allogeneic Hematopoietic Cell Transplantation for Patients With Hematologic Disorders Who Are Undergoing Dose-Adjusted Treatment With A Maximally Intensive Busulfex-Based Therapeutic Regimen
RATIONALE: Giving chemotherapy, such as fludarabine and busulfan, before a donor peripheral
stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop
the patient's immune system from rejecting the donor's stem cells. When the healthy stem
cells from a donor are infused into the patient they may help the patient's bone marrow make
stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted
cells from a donor can make an immune response against the body's normal cells. Giving a
monoclonal antibody, alemtuzumab, before the transplant and tacrolimus after the transplant
may stop this from happening.
PURPOSE: The phase I portion of this trial identified the maximum tolerated dose of busulfan
after treating 40 patients on a dose-escalation scheme. We are now treating an additional 26
patients on the phase II portion of the trial at a PK-directed dose of total AUC 6912
uM-min/24 hours. We transitioned to the Phase II portion of the study in October 2009.
OBJECTIVES:
Primary
- Phase I Objective: To identify the maximum tolerated dose of continuous infusion IV
busulfan based on blood levels derived from a test dose in conjunction with
fludarabine, ATG and methotrexate plus tacrolimus for GVHD prophylaxis
- Phase II Objective: To determine the one-year disease-free survival (DFS) rate at the
maximum tolerated dose identified during Phase I of the trial (target AUC 6912)
Secondary
- Determine the overall and disease-free survival of patients treated with this regimen.
- Determine the dose-limiting toxicities of this regimen in these patients.
- Determine the capacity of test dosing of busulfan that would result in the desired area
under the curve concentration exposure of patients receiving a full-dose busulfan
regimen.
- Determine the incidence of graft-vs-host disease and DNA chimerism between 1 month and
2 years post-transplantation in these patients.
- Compare the overall survival (OS) and disease-free survival (DFS) rates for patients
treated with Campath vs. patients treated with ATG/Methotrexate for GVHD control
OUTLINE: This is a non-randomized, open-label, parallel group study of busulfan. Patients
are stratified according to donor relationship (matched related donor [MRD] vs matched
unrelated donor [MUD]).
- Conditioning regimen: Patients receive fludarabine phosphate IV over 30 minutes on days
-7 to -3 and busulfan IV over 2 hours once within days -15 to -10 and then IV
continuously over 90 hours on days -7 to -4. Patients with a MRD also receive
Methotrexate (MTX) on Days +1, +3, and +6. Patients with a MUD receive ATG on Days -3
and -2 and MTX on Days +1, +3 and +6.
Phase I portion only: Cohorts of 3-6 patients receive escalating doses of busulfan until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Allogeneic peripheral blood stem cell transplantation: Patients undergo allogeneic
peripheral blood stem cell transplantation on day 0. Patients then receive sargramostim
(GM-CSF) subcutaneously beginning on day 5 and continuing until blood counts recover.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive oral tacrolimus twice daily
on days -1 to 180 or days -1 to 240.
- Donor lymphocyte infusion (DLI): Patients who do not achieve CR, do not have GVHD, and
have been off immunosuppressants for at least 30 days may receive up to 3 DLIs, at
least 8 weeks apart, after completion of tacrolimus.
After the completion of study treatment, patients are followed periodically for up to 5
years.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540340 -
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
|
Phase 1 | |
Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
Completed |
NCT00001512 -
Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
|
Phase 1 | |
Recruiting |
NCT05618041 -
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
|
N/A | |
Completed |
NCT01410630 -
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
|
||
Active, not recruiting |
NCT04270266 -
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma
|
N/A | |
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Completed |
NCT01949883 -
A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma
|
Phase 1 | |
Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
Recruiting |
NCT05019976 -
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
|
N/A | |
Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
Completed |
NCT04434937 -
Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
|
Phase 2 | |
Completed |
NCT01855750 -
A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
|
Phase 3 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT00775268 -
18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03936465 -
Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer
|
Phase 1 |