CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Haploidentical Bone Marrow Transplantation +1 morebiological
Likely dose
Fludarabine 30 mg/m² IV on Days -6, -5, -4, -3, -2; Cyclophosphamide 14.5 mg/kg IV on Days -6 and -5; TBI 200 cGy on Day -1; Post-transplant Cyclophosphamide 50 mg/kg IV on Days 3 and 4; Tacrolimus IV/orally from Day 5 (target 5-15 mg/mL); MMF 15 mg/kg orally three times daily from Day 5AI-extracted
Key inclusion· 10
  • ✓Age 21-70 years (1-21 years eligible if ineligible for BMT CTN #0501)
  • ✓HLA haploidentical donor (5/10 minimum match, with identity on at least one allele of each HLA-A, -B, -Cw, -DRB1, -DQB1)
  • ✓Recent cytotoxic chemotherapy within 3 months of consent
  • ✓Acute leukemias in second or subsequent complete remission (CR)
Key exclusion· 6
  • ✕Has HLA-matched related donor or 7-8/8 allele matched related donor
  • ✕Prior allogeneic hematopoietic stem cell transplant
  • ✕Autologous hematopoietic stem cell transplant within 3 months before study entry
  • ✕HIV infection or known HIV positive serology

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00849147
NCT00849147Phase 2Completed
CompareCT.gov

A Multi-Center, Phase II Trial of Nonmyeloablative Conditioning (NST) and Transplantation of Partially HLA-Mismatched Bone Marrow From Related Donors for Patients With Hematologic Malignancies (BMT CTN #0603)

Medical College of Wisconsin·interventional·Posted Feb 23, 2009·Updated Jan 4, 2023

In Brief

A Phase 2 clinical trial evaluating Haploidentical Bone Marrow Transplantation and GVHD prophylaxis for Precursor B-Cell Lymphoblastic Leukemia-Lymphoma and 5 related conditions. Completed, enrolled 55 participants across 17 sites.

Detailed Summary

Bone marrow transplants are one treatment option for people with leukemia or lymphoma. Family members or unrelated donors with a similar type of bone marrow usually donate their bone marrow to the transplant patients. This study will evaluate the effectiveness of a new type of bone marrow transplant-one that uses lower doses of chemotherapy and bone marrow donated from family members with only partially matched bone marrow-in people with leukemia or lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrecursor B-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Burkitt Lymphoma, Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 23, 2009
Enrollment StartOct 1, 2008
Primary CompletionJun 1, 2011
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.4 years ago

Interventions

Haploidentical Bone Marrow Transplantationbiological

The transplant preparative regimen is listed below. The - sign is the number of days before the transplant. * Fludarabine: 30 mg/m2 intravenously (IV) on Days -6, -5, -4, -3, and -2 * Cyclophosphamide (Cy): 14.5 mg/kg IV on Days -6 and -5 * Total body irradiation (TBI): 200 centigray (cGy) on Day -1 Day 0 is the day of the infusion of non-T-cell depleted bone marrow. The bone marrow will be obtained from haploidentical related donor.

GVHD prophylaxisbiological

The GVHD prophylaxis regimen will consist of the following: * Cy: 50 mg/kg IV on Days 3 and 4 * Tacrolimus: (IV or orally) beginning on Day 5 with dose adjusted to maintain a level of 5 to 15 mg/mL * Mycophenolate mofetil (MMF): 15 mg/kg orally three times a day (TID) beginning on Day 5; maximum dose will be 1 g orally TID * Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg/day beginning on Day 5 until absolute neutrophil count (ANC) is greater than or equal to 1,000/mm\^3 for 3 consecutive days