CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 361 enrolled
Drug / intervention
anti-thymocyte globulin +8 morebiological
Likely dose
Total-body irradiation given twice daily for 3 days; busulfan, cyclophosphamide, fludarabine phosphate, melphalan, thiotepa, carboplatin, and etoposide IV; anti-thymocyte globulin IV (doses not specified in protocol summary)AI-extracted
Key inclusion· 10
  • ✓Severe aplastic anemia with marrow cellularity <25% or 25–50% with <30% hematopoietic cells, OR ≥2 abnormal peripheral blood counts (reticulocyte <1%, platelet <20,000/mm³, neutrophil <500/mm³)
  • ✓Histologically confirmed acute leukemia (AML or ALL) in first remission at high risk OR resistant/recurrent after chemotherapy
  • ✓Chronic myeloid leukemia in chronic, accelerated, or blast phase
  • ✓Lymphoproliferative or myeloproliferative disease (myelofibrosis, refractory anemia, RAEB, CMML, or transformed polycythemia vera/essential thrombocythemia)
Key exclusion· 11
  • ✕Prior radiotherapy exceeding specified dose limits to mediastinum, heart, whole lungs, small bowel, kidneys, whole liver, cranial spinal, brain, or retina
  • ✕Uncontrolled bacterial, viral, or fungal infection
  • ✕HIV positive
  • ✕Hepatitis B surface antigen positive

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

Search/NCT00003816
NCT00003816Phase 3Completed
CompareCT.gov

Allogeneic Blood or Marrow Transplantation for Hematologic Malignancy and Aplastic Anemia

Roswell Park Cancer Institute·interventional·Posted Jan 27, 2003·Updated Aug 13, 2021

In Brief

A Phase 3 clinical trial evaluating anti-thymocyte globulin, busulfan, and 7 other interventions for Chronic Myeloproliferative Disorders and 7 related conditions. Completed, enrolled 361 participants across 1 site.

Detailed Summary

RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor stem cell helps stop the growth of cancer or abnormal cells. It may also 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. It is not yet known which combination chemotherapy regimen is most effective when given before a donor stem cell transplant in treating aplastic anemia or hematologic cancer. PURPOSE: This phase II/III trial is studying different combination chemotherapy regimens to compare how well they work when given before donor stem cell transplant in treating patients with aplastic anemia or hematologic cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myeloproliferative Disorders, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Nonmalignant Neoplasm, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartOct 19, 1998
Primary CompletionJul 12, 2019
TodayJul 2, 2026
Enrollment to primary: 20.7 yearsPosted 23.4 years ago

Interventions

anti-thymocyte globulinbiological

Given IV

busulfandrug

Given IV

carboplatindrug

Given IV

cyclophosphamidedrug

Given IV

etoposidedrug

Given IV

fludarabine phosphatedrug

Given IV

melphalandrug

Given IV

thiotepadrug

Given IV

total-body irradiationradiation

Given twice daily for 3 days