Nonmyeloablative Allogeneic Transplant

Not Applicable

Completed

• Conditions: Aplastic Anemia; Breast Cancer; Paroxysmal Nocturnal Hemoglobinuria; Acute Myelogenous Leukemia; Sarcoma; Ovarian Cancer; Acute Lymphocytic Leukemia; Myelodysplastic Syndrome; Chronic Myelogenous Leukemia; Chronic Lymphocytic Leukemia
• Interventions: Procedure: Nonmyeloablative Allogeneic Transplant

• Registration Number: NCT01272817
• Lead Sponsor: 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.

Detailed Description

same

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cladribine + melphalan	Nonmyeloablative Allogeneic Transplant	Cladribine + melphalan conditioning
TLI	Nonmyeloablative Allogeneic Transplant	Total lymphoid irradiation conditioning

Primary Outcome Measures

Name	Time	Method
Engraftment	One year	Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.

Secondary Outcome Measures

Name	Time	Method
Graft-versus-host disease	One year	Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol.

Trial Locations

Locations (1)

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States