Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Hematologic Neoplasms

Preleukemia

Myelodysplastic Syndromes

Hematologic Diseases

Precancerous Conditions

Antineoplastic Agents

All Drugs and Chemicals

Melphalan

Alemtuzumab

Clofarabine

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

Antimetabolites

Clofarabine will be administered as a 2-hour IV infusion on Days 1 through 5 at approximately the same time everyday (4 dose levels).

Campath

Stem Cell Transplant

Andrew Artz, MD

This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.

Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

Toxicity was scored according to NCI/CTC version 3

Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first.

University of Chicago

Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.

Clofarabine, Melphalan, and Alemtuzumab

Age, Continuous

Sex: Female, Male

Dr. Andrew Artz

Grade 1-2

Grade 3-4

Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation

74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days

Overall Survival (OS)

Grade 5

Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation

Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation

Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation

Progression-free Survival (PFS)

Treatment-related Mortality (TRM)

Relapse Rate

Overall Study

Spots Global Cancer Trial Database for Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial