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Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H

This study has been completed.
Sponsor:
Collaborators:
The Methodist Hospital System
Texas Children's Hospital
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00048412
First received: October 30, 2002
Last updated: April 9, 2007
Last verified: April 2007
  Purpose
  1. To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy.
  2. To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen.
  3. To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.

Condition Intervention Phase
Myelodysplastic Disorders
Leukemia
Multiple Myeloma
Plasma Cell Dyscrasia
Lymphoproliferative Disorders
Drug: FLUDARABINE
Drug: CAMPATH 1H
Drug: FK50
Procedure: Stem Cell Collection and Infusion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM)

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Estimated Enrollment: 40
Study Start Date: June 2000
Detailed Description:

This is a two arm study in which outcomes will be assessed independently in recipients of HLA matched sibling transplants and recipients of unrelated or mismatched family donor transplants, although both groups will receive identical treatments.

The following will be given to the patient after admission:

Day - 6: Total body irradiation

Day - 5 to - 2: Fludarabine and Campath 1H

Day - 1: Day of rest

Day 0: Stem cell transplant (infusion)

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Diagnosis of myelodysplastic disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia and Hodgkins Disease) or Renal Cell Carcinoma.
  2. Conditions that increase treatment related mortality (need one or more to be eligible):

    1. Greater to or equal to 50 years of age.
    2. EF of less than 45%
    3. DLCO less than 50% of FEV1 50-75% of predicted value.
    4. Diabetes Mellitus
    5. Renal Insufficiency (but creatine clearance not less than 25ml/min).
    6. Prior recent history of systemic fungal infection.
    7. 3rd or greater remission of AML or ALL
    8. More than 1 year of diagnosis (CML or Myeloma patients)
    9. Multiple types of treatment regimens. (equal to or more than 3)
    10. Prior autologous or allogeneic stem cell transplantation.
    11. Significant grade III or IV neurologic or hepatic toxicity from previous treatment.
    12. No matched sibling donor.
  3. Available healthy donor without any contraindications for donation. 5/6 or 6/6 related donor. 5/6 or 6/6 unrelated donor (molecular typing for DRB1)
  4. Patient and/or responsible person able to understand consent.
  5. Age between birth and 70 years.
  6. For women of childbearing potential, negative pregnancy test.

Exclusion criteria

  1. Patient is pregnant, lactating or unwilling to use contraceptives
  2. HIV positive patient
  3. Uncontrolled intercurrent infection
  4. Refractory AML, or ALL
  5. Untreated Blast Crisis for CML
  6. Uncontrolled High-grade lymphoproliferative disease/lymphoma.
  7. Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)
  8. Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)
  9. Hemodialysis dependent
  10. Active Hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x normal.
  11. Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months)
  12. Active CNS disease from hematological disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048412

Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
The Methodist Hospital System
Texas Children's Hospital
Center for Cell and Gene Therapy, Baylor College of Medicine
Investigators
Principal Investigator: George Carrum, MD Baylor College of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00048412     History of Changes
Other Study ID Numbers: H8714, DIMSUM
Study First Received: October 30, 2002
Last Updated: April 9, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms, Plasma Cell
Paraproteinemias
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Vascular Diseases
Alemtuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014