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Trial: NCT00003187 [RDF]

Label NCT00003187
Slug nct00003187
Trialid NCT00003187
Lookup name NCT00003187
Provenance http://clinicaltrials.gov/show/NCT00003187?displayxml=true
Lastchanged date February 23, 2010
Firstreceived results date
Firstreceived date May 2, 2000
Id info nct id NCT00003187
Overall status Completed
Id info secondary id P30CA016059
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 19
Number of arms
Is section 801
Is fda regulated No
Brief title Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma
Acronym
Official title The Unrelated Donor Marrow Transplantation Trial
Study type Interventional
Id info nct alias
Completion date February 2005
Verification date February 2010
Why stopped
Id info org study id CDR0000066016
Required header url https://clinicaltrials.gov/show/NCT00003187
Study design Allocation: Randomized, Primary Purpose: Treatment
Source Virginia Commonwealth University
Primary completion date February 2005
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 08, 2016
Phase Phase 2/Phase 3
Start date May 1995
Has expanded access No
Biospec descr
Detailed description OBJECTIVES: I. Compare the disease free survival of patients with leukemia, myelodysplasia, or lymphoblastic lymphoma after treatment with conventional (non-T cell depleted) or T cell depleted unrelated donor bone marrow transplantation. II. Compare the incidence of primary and secondary graft failure, acute and chronic graft-vs-host disease, complications (infection, veno-occlusive disease, interstitial pneumonitis), and relapse in these patients after these treatments. III. Compare the incidence of other malignancies, lymphoproliferative disorders, and post-transplant myelodysplasia in these patients after these treatments. OUTLINE: This is a randomized, multicenter study. Patients will be stratified according to institution. Patients are assigned to one of two treatment arms, one with conventional bone marrow transplantation (arm I) and one with T cell depletion of the bone marrow (arm II). Arm I: Patients receive cyclophosphamide on days -6 and -5. Total body irradiation (TBI) is administered on days -4 to 0, although this order may be reversed. Males with ALL receive a testicular boost of radiation therapy. Bone marrow is infused on day 0. Patients receive cyclosporine beginning on day -1 and methotrexate IV on days 1, 3, 6, and 11. Arm II: T cell depletion is conducted by 2 different methods, according to the institution, and treatment varies depending on the method used. Method I is by T10B9 depletion and Method II is by counterflow elutriation depletion. Method I: Depending on the institution, some patients receive TBI on days -9 to -7 (before chemotherapy) (Course I) and some receive TBI on days -3 to -1 (after chemotherapy) (Course II). Course I also includes cytarabine IV on days -5 to -3, cyclophosphamide IV on days -2 and -1, and methylprednisolone IV on days -2 to 0 and 5-18. Bone marrow infusion is administered on day 0. Cyclosporine begins on day -1. Course II includes cytarabine IV on days -7 to -4 and cyclophosphamide on days -6 to -5. Methylprednisolone IV is administered on days -2 to 0 and 5-18. Bone marrow infusion is administered on day 0. Cyclosporine begins on day 0. Method II: Preparative therapy varies according to the disease category. Acute lymphoblastic leukemia: Patients undergo TBI on days -7 to -4. Males receive testicular boost on day -7, and all receive electron boost to anterior and posterior chest wall on days -5 and -4. Cyclophosphamide IV is administered on days -3 and -2. Bone marrow infusion is administered on day 0. Acute nonlymphocytic leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome: Patients receive cyclophosphamide IV on days -7 and -6, followed by TBI on days -4 to -1. Bone marrow infusion is administered on day 0. Patients receive methylprednisolone IV every 12 hr on days -2,-1, and 5-19. Cyclosporine is administered from day -3 to day 180. All patients on both arms receive filgrastim (granulocyte colony-stimulating factor; G-CSF) beginning on day 7 post-transplant. Patients are followed weekly for the first 14 weeks, at day 100, every 6 months for 2 years, then annually thereafter. PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study within 4 years.
Condition browse ef42f353f09351cc2d1b4fefdd701fdd
Intervention browse 78748bc6d2ef47910b9fac7c850e15e7
Responsible party 9741ce7721688ff8d38b188e48d00543
Overall contact None
Overall contact backup None
Sponsor group 8da0f1494410be95a6c8b6ed1f691732
Oversight info United States: Federal Government (Oversight_info)
Eligibility e8d5c80f68a116c337f7f7b16f2b9e41
Keywords accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission More →
Conditions Leukemia, Lymphoma, Myelodysplastic Syndromes
Locations 071c8420ed775d08f0e6d787c23a9c65, 2693b643d3485f5c282ca86073b8532b, 2ddd11e423f994cf53e386d19cd3a703, 333421fe63285144127a547857be2106, 47dfd588d619d8b3911f0895bbb55473, 646b009a68ec812516ccbd20d991c7b6, 7cb4611cc5e7776df74cfcb218c36145, 7efb87be29d5497efbaf84eeb942092e, 88769ee55ea8890f125cfd4aca9c2082, 90c5c656065fbdb62c603a669095f403, a8f690eeac84f8b65a558ef87ee2b1b5, d4f864b0848dd222ca516ef70f88626d, f3970e6cd9e16574cd2d581ee98e4487
Links None
Results references None
Arm groups None
Location countries United States
Interventions cyclosporine (Intervention), cyclophosphamide (Intervention), cytarabine (Intervention), radiation therapy (Intervention), methylprednisolone (Intervention), filgrastim (Intervention), methotrexate (Intervention), allogeneic bone marrow transplantation (Intervention), in vitro-treated bone marrow transplantation (Intervention)
Secondary outcomes None
References None
Primary outcomes None
Removed countries None
Overall officials 8d3973c2a10e8a8ada48f7822d70acf8