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Completed

NCT Number: NCT01272817

Nonmyeloablative Allogeneic Transplant

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.

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Key information

Conditions

Aplastic Anemia Acute Lymphocytic Leukemia Acute Myelogenous Leukemia Adenocarcinoma Adnexal Diseases Anemia Anemia, Aplastic Anemia, Hemolytic Blood Protein Disorders Bone Marrow Diseases Bone Marrow Failure Disorders Breast Cancer Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Renal Cell Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia Chronic Myelogenous Leukemia Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinuria, Paroxysmal Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Hodgkin's Lymphoma Immune System Diseases Immunoproliferative Disorders Kidney Diseases Kidney Neoplasms Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Mantle Cell Lymphoma Melanoma Multiple Myeloma Myelodysplastic Syndrome Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Plasma Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-Hodgkin's Lymphoma Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Paraproteinemias Paroxysmal Nocturnal Hemoglobinuria Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Renal Cell Carcinoma Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Thymoma Thymus Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vascular Diseases Waldenstrom Macroglobulinemia

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Green Hospital

La Jolla, California, 92037, United States

About this study

same

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 55 years or
  • Age < 55 and LVEF < 45% or creatinine clearance < 60 ml/min
  • Ability to cover the cost of the transplant, necessary medications, and transportation/housing.
  • 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

  • Prior allogeneic stem cell or bone marrow transplant
  • Current or past history of invasive mycotic infection
  • Breast Feeding

Treatment and study plan

Nonmyeloablative Allogeneic Transplant

Procedure

Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Scripps Health

Other

Registry information

Official study title

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation

Acronym: Mini-allo

Important dates

Study start
2001
Primary completion
2015
Study completion
2015
First posted
Jan 10, 2011
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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