CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 210 enrolled
Drug / intervention
cyclophosphamide +5 moredrug
Likely dose
Cyclophosphamide and fludarabine phosphate (specific doses not stated in protocol)AI-extracted
Key inclusion· 11
  • Acute leukemia in second or later complete remission OR first CR with poor-risk cytogenetics (chromosome 5/7 alteration, multiple abnormalities, or Philadelphia chromosome positive)
  • CML in first chronic phase refractory to interferon alfa or imatinib, or in second/subsequent chronic phase
  • CLL with prior chemotherapy with nucleoside analog and remission <6 months, OR one prior therapy with high-risk features (17p/11q abnormalities, Zap70 mutations, unmutated immunoglobulin heavy chain)
  • Hodgkin lymphoma ineligible for autologous SCT (LVEF <45%, FEV1/FVC <50% predicted, bilirubin >2.0 mg/dL, creatinine >2.0 mg/dL)
Key exclusion· 8
  • Smoldering myeloma
  • LVEF <35%
  • FEV1 or FVC <40% of predicted (or <60% if prior thoracic/mantle radiotherapy)
  • Bilirubin >3.1 mg/dL

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

Search/NCT00134004
NCT00134004Phase 2Completed

A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Bone Marrow for Patients With Hematologic Malignancies

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Aug 24, 2005·Updated Oct 6, 2015

In Brief

A Phase 2 clinical trial evaluating cyclophosphamide, fludarabine phosphate, and 4 other interventions for Chronic Myeloproliferative Disorders and 4 related conditions. Completed, enrolled 210 participants across 3 sites.

Detailed Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and radiation therapy before a donor bone marrow transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 24, 2005
Enrollment StartOct 1, 2004
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 20.9 years ago

Interventions

cyclophosphamidedrug

fludarabine phosphatedrug

mycophenolate mofetildrug

tacrolimusdrug

allogeneic bone marrow transplantationprocedure

radiation therapyradiation