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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.
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 Identifier:
First received: October 30, 2002
Last updated: April 9, 2007
Last verified: April 2007
  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
Intervention Model: Parallel Assignment
Masking: None (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)


Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00048412

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
Principal Investigator: George Carrum, MD Baylor College of Medicine
  More Information Identifier: NCT00048412     History of Changes
Other Study ID Numbers: H8714
Study First Received: October 30, 2002
Last Updated: April 9, 2007

Additional relevant MeSH terms:
Multiple Myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell
Pathologic Processes
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Antineoplastic Agents processed this record on August 23, 2017