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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00048412
Recruitment Status : Completed
First Posted : November 1, 2002
Last Update Posted : January 18, 2020
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by (Responsible Party):
George Carrum, Baylor College of Medicine

Brief Summary:
  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 or disease Intervention/treatment 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

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)

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
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)
Study Start Date : June 2000
Actual Primary Completion Date : November 12, 2004
Actual Study Completion Date : November 12, 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00048412

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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
Center for Cell and Gene Therapy, Baylor College of Medicine
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Principal Investigator: George Carrum, MD Baylor College of Medicine
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Responsible Party: George Carrum, Professor, Baylor College of Medicine Identifier: NCT00048412    
Other Study ID Numbers: H8714
First Posted: November 1, 2002    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoproliferative Disorders
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
Antineoplastic Agents, Immunological