Campath-1H and Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies

NCT00038883 | Terminated

• 1 other identifier: ID99-410
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

High dose chemotherapy followed by transplantation of allogeneic hematopoietic stem cell with the use of Campath-1h, a monoclonal antibody that have a synergistic effect to chemotherapy with minimal toxicity. In addition Campath-1H can improve engraftment of donor cells through its immunosuppressive properties.

Conditions

Leukemia, Lymphocytic, Chronic; Leukemia, Lymphocytic, Acute; Lymphoma, Low-Grade; Lymphoma, T-Cell; Lymphoma, B-Cell

Keywords

Lymphoid Malignancies; Chronic Lymphocytic Leukemia; Acute Lymphoblastic Leukemia; Low grade Lymphoma; B and T cell Lymphoma of the intermediate and high grade

Outcome Measures

Primary Outcomes (1)

• CAMPATH 2-year event-free survival rate

  2 years

Study Arms (1)

Campath-1H

EXPERIMENTAL

10 mg/day x 5

Drug: Campath-1H

Interventions

Campath-1H DRUG

10 mg/day x 5, starting with the first day of chemotherapy

Also known as: Alemutuzumab, Campath

Campath-1H

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• B or T-cell lymphoid disease, not eligible for non-myeloablative transplantation.
• Patients in relapse after failing conventional chemotherapy.
• Patients with HLA-identical or one-antigen mismatched sibling, or a matched unrelated donor.
• Performance status \</=2.

You may not qualify if:

• Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies.
• Less than 4 weeks since prior chemotherapy.
• Pregnancy or lactation.
• HIV or HTLV-I positivity.
• Serum creatinine \>1.6 mg/dl or serum bilirubin \>0.2 mg/dl unless due to tumor, SGPT \>/= 2 x NI
• PFT-DCLO\<50%, cardiac EF \<50% of predicted levels.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Leudosite: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Lymphoma, B-Cell

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Issa F. Khouri, MD, BS

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2002
• First Posted: June 7, 2002
• Study Start: April 9, 2001
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

US (1)