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Nonmyeloablative Allogeneic Transplant (Mini-allo)

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: NCT01272817
Recruitment Status : Unknown
Verified December 2013 by Jeffrey Andrey, MD, Scripps Health.
Recruitment status was:  Recruiting
First Posted : January 10, 2011
Last Update Posted : December 6, 2013
Information provided by (Responsible Party):
Jeffrey Andrey, MD, Scripps Health

Brief Summary:
Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.

Condition or disease Intervention/treatment Phase
Aplastic Anemia Paroxysmal Nocturnal Hemoglobinuria Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Myelodysplastic Syndrome Chronic Myelogenous Leukemia Chronic Lymphocytic Leukemia Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Mantle Cell Lymphoma Multiple Myeloma Waldenstrom Macroglobulinemia Breast Cancer Renal Cell Carcinoma Melanoma Sarcoma Ovarian Cancer Thymoma Procedure: Nonmyeloablative Allogeneic Transplant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation
Study Start Date : October 2001
Estimated Primary Completion Date : January 2015

Arm Intervention/treatment
Cladribine + melphalan
Cladribine + melphalan conditioning
Procedure: Nonmyeloablative Allogeneic Transplant
Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day

Total lymphoid irradiation conditioning
Procedure: Nonmyeloablative Allogeneic Transplant
Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)

Primary Outcome Measures :
  1. Engraftment [ Time Frame: One year ]
    Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.

Secondary Outcome Measures :
  1. Graft-versus-host disease [ Time Frame: One year ]
    Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age > 55 years or
  2. Age < 55 and LVEF < 45% or creatinine clearance < 60 ml/min
  3. Ability to cover the cost of the transplant, necessary medications, and transportation/housing.
  4. Caregiver must be available while outpatient

Guidelines for Cladribine-Melphalan-based conditioning:

  • Bone Marrow Failure States Severe Aplastic Anemia (relapsed following immunosuppressive therapy) Paroxysmal Nocturnal Hemoglobinuria (poor prognostic features or hemosiderosis)
  • AML (first CR except for t(15;17), inv16, t(8,21); second CR; relapse failing second induction attempt)
  • ALL (first CR with at least one poor prognostic feature; second or greater CR; relapse failing reinduction attempt)
  • CML (chronic phase; accelerated phase; blast phase following reinduction attempt; 2nd chronic or accelerated phase following gleevec therapy
  • Hodgkin's lymphoma (first or greater relapse)
  • Non-Hodgkin's Lymphoma
  • Aggressive Histology (includes T Cell NHL) Incomplete response to induction Second CR Sensitive or refractory relapse
  • Indolent Histology Second or greater relapse
  • Mantle Cell Lymphoma (any Stage - must have received induction chemotherapy)
  • Multiple Myeloma (10% residual plasmacytosis following anthracycline-based chemotherapy or residual disease following autologous transplant)
  • Waldenstrom Macroglobulinemia (must have failed either purine analogue-based chemotherapy (Fludara or 2CdA) or standard CVP therapy; hyperviscosity or cytopenias)

Guidelines for total lymphoid irradiation-based conditioning

  • MDS (RA, RARS)
  • CLL (Rai stage III or IV - must have received at least two different treatment regimens in the past)
  • Breast Cancer (symptomatic metastatic disease, who have failed standard chemotherapy)
  • Renal Cell Cancer (metastatic disease at multiple sites)
  • Malignant Melanoma (metastatic disease at multiple sites)
  • Sarcoma (all subtypes presently, unresectable metastatic disease)
  • Ovarian Cancer (stage III or IV, platinum insensitive disease, i.e. progression within 6 months of initial platinum chemotherapy)
  • Thymoma (unresectable disease)

Exclusion Criteria:

  1. Prior allogeneic stem cell or bone marrow transplant
  2. Current or past history of invasive mycotic infection
  3. Breast Feeding

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): NCT01272817

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Contact: Carol Burian 858-554-2845

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United States, California
Scripps Green Hospital Recruiting
La Jolla, California, United States, 92037
Contact: Cynthia Nelson, R.N.    858-554-2814   
Contact: Laurie Cobarrubia, R.N.    858-554-2853   
Principal Investigator: Jeffrey W. Andrey, M.D.         
Sub-Investigator: James R. Mason, M.D.         
Sub-Investigator: William E. Miller, M.D.         
Sponsors and Collaborators
Scripps Health
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Principal Investigator: Jeffrey W. Andrey, M.D. Scripps Health

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Responsible Party: Jeffrey Andrey, MD, Director, Unrelated Donor Transplantation, Scripps Health Identifier: NCT01272817     History of Changes
Other Study ID Numbers: IRB#13-6255
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013
Keywords provided by Jeffrey Andrey, MD, Scripps Health:
Nonmyeloablative transplant
Allogeneic transplant
Additional relevant MeSH terms:
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Multiple Myeloma
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Lymphoma, Mantle-Cell
Carcinoma, Renal Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Waldenstrom Macroglobulinemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Anemia, Aplastic
Hemoglobinuria, Paroxysmal
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases