At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 60 enrolled

Drug / intervention

alemtuzumab +6 morebiological

Likely dose

Alemtuzumab dose escalation with low-dose TBI and fludarabine (specific doses not stated)AI-extracted

Key inclusion· 8

✓Patients must be ineligible for conventional transplants and have disease expected to be stable for ≥100 days without chemotherapy
✓AML must have <5% marrow blasts at time of transplant
✓ALL must have <5% blasts at time of transplant
✓CML must have <5% marrow blasts at time of transplant (beyond chronic phase 1 if prior myelosuppressive chemotherapy or HSCT)

Key exclusion· 16

✕Presence of circulating leukemic blasts in peripheral blood for AML, ALL, or CML
✕Positive cross-match between donor and recipient
✕Patients homozygous at mismatched HLA class I locus
✕Rapidly progressive intermediate or high grade NHL

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

Search/NCT00040846

NCT00040846Phase 2Completed

Compare CT.gov

Campath® [Alemtuzumab] Dose Escalation, Low-Dose TBI and Fludarabine Followed by HLA Class I Mismatched Donor Stem Cell Transplantation for Patients With Hematologic Malignancies - A Multi-Center Trial

Fred Hutchinson Cancer Center·interventional·Posted Jan 27, 2003·Updated Jan 29, 2020

In Brief

A Phase 2 clinical trial evaluating alemtuzumab, fludarabine phosphate, and 5 other interventions for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and 99 related conditions. Completed, enrolled 60 participants across 7 sites in 2 countries.

Detailed Summary

This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal 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. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after transplant may stop this from happening.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

CountriesItaly, United States

CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 2001

First PostedJan 2003

Primary CompletionDec 2009

TodayJul 2026

First PostedJan 27, 2003

Enrollment StartNov 1, 2001

Primary CompletionDec 1, 2009

TodayJul 2, 2026

Enrollment to primary: 8.1 yearsPosted 23.4 years ago

Interventions

alemtuzumabbiological

Given IV

fludarabine phosphatedrug

Given IV

total-body irradiationradiation

Undergo TBI

allogeneic hematopoietic stem cell transplantationprocedure

Undergo allogeneic HSCT

peripheral blood stem cell transplantationprocedure

Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetildrug

Given PO

cyclosporinedrug

Given IV or PO