CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 204 enrolled
Drug / intervention
Fludarabine +3 moredrug
Likely dose
Fludarabine 30 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00683046
NCT00683046Phase 2Completed
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T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

University of Chicago·interventional·Posted May 23, 2008·Updated Nov 22, 2016

In Brief

A Phase 2 clinical trial evaluating Fludarabine, Melphalan, and 2 other interventions for Acute Myelogenous Leukemia and 8 related conditions. Completed, enrolled 204 participants across 1 site.

Detailed Summary

Objectives: 1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies. 2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation. 3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myelogenous Leukemia, Lymphoid Leukemia, Chronic Myelogenous Leukemia, Malignant Lymphoma, Hodgkin's Disease, Chronic Lymphocytic Leukemia, Myeloproliferative Disorder, Anemia, Aplastic, Myelodysplastic Syndromes
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 23, 2008
Enrollment StartNov 1, 2001
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 13.1 yearsPosted 18.1 years ago

Interventions

Fludarabinedrug

Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.

Melphalandrug

Melphalan 140 mg/m2 IV on day -2.

Stem cellsdrug

Stem cell infusion on day 0.

Campathdrug

Campath, 20 mg IV on day -7, 6, -5, -4, and -3.