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Nonmyeloablative Allogeneic Transplant (Mini-allo)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Scripps Health
Sponsor:
Information provided by (Responsible Party):
Jeffrey Andrey, MD, Scripps Health
ClinicalTrials.gov Identifier:
NCT01272817
First received: January 6, 2011
Last updated: December 5, 2013
Last verified: December 2013

January 6, 2011
December 5, 2013
October 2001
January 2015   (final data collection date for primary outcome measure)
Engraftment [ Time Frame: One year ] [ Designated as safety issue: No ]
Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.
Same as current
Complete list of historical versions of study NCT01272817 on ClinicalTrials.gov Archive Site
Graft-versus-host disease [ Time Frame: One year ] [ Designated as safety issue: No ]
Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol.
Same as current
Not Provided
Not Provided
 
Nonmyeloablative Allogeneic Transplant
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
  • Procedure: Nonmyeloablative Allogeneic Transplant
    Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)
  • Cladribine + melphalan
    Cladribine + melphalan conditioning
    Intervention: Procedure: Nonmyeloablative Allogeneic Transplant
  • TLI
    Total lymphoid irradiation conditioning
    Intervention: Procedure: Nonmyeloablative Allogeneic Transplant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
January 2015   (final data collection date for primary outcome measure)

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)
  • MDS (RAEB, RAEBiT, CMMoL)
  • 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
Both
18 Years to 72 Years
No
Contact: Carol Burian 858-554-2845 burian.carol@scrippshealth.org
United States
 
NCT01272817
IRB#13-6255
No
Jeffrey Andrey, MD, Scripps Health
Scripps Health
Not Provided
Principal Investigator: Jeffrey W. Andrey, M.D. Scripps Health
Scripps Health
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP