Study of Low Intensity Conditioning and Immunotherapy for High-Risk Cancers of the Blood

NCT00143884 | Terminated Phase 2

• 1 other identifier: UMCC 9979
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This research project will focus on whether it is safe and effective to rely on donor cells to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell transplant.

Conditions

Leukemia; Lymphoma, Low-Grade; Lymphoma, Non-Hodgkin's; Multiple Myeloma; Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• To conduct a phase I-II trial of prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies

Secondary Outcomes (1)

• To evaluate both surrogate markers of GVHD (with a cytokine panel) and minimal residual disease and correlate these with clinical outcomes during the above trial

Interventions

Reduced intensity conditioning PROCEDURE

Prophylactic donor leukocyte infusions PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• One of the following hematological malignancies:
• Chronic myelogenous leukemia
• Accelerated phase
• Blast phase
• Acute myelogenous leukemia
• First or greater complete remission if high risk features: abnormalities of chromosomes with known poor prognosis 5 or 7.
• Relapsed or refractory patients with ≤ 30% blasts
• Aged 55 years or older in any disease state beyond first remission if blast percentage is \< 30%.
• Acute lymphoblastic leukemia
• First complete remission if high risk features: t(4;11)
• Second complete remission if relapse occurs within the first 12 months of therapy
• Third or greater complete remission
• Relapsed or refractory patients with ≤ 30% blasts
• Aged 55 years or old in second in any disease state beyond first remission if blast percentage is \< 30%.
• Myelodyplastic syndromes

You may not qualify if:

• HIV positive patients not eligible
• Pregnant
• /6 HLA match for HLA-A, B, and DR
• Age 3-70 years, good general health
• No contraindication to G-CSF stimulation
• No contraindication to leukapheresis of peripheral blood stem cells
• Good general health
• HIV positive or history of HIV risk factors
• Presence of other diseases transmissible by blood that pose unacceptable risk to the study subject.
• Pregnant
• Medical or psychological conditions that would make the donor unlikely to tolerate G-CSF injections or leukapheresis

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Leukemia; Lymphoma, Non-Hodgkin; Multiple Myeloma; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Bone Marrow Diseases

Study Officials

• John E. Levine, MS MD

  The Univeristy of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: ECT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: March 1, 2000
• Last Updated: April 23, 2007

Record last verified: 2007-01

Locations

US (1)