NCT01272817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

14 years

First QC Date

January 6, 2011

Last Update Submit

November 21, 2022

Conditions

Aplastic AnemiaParoxysmal Nocturnal HemoglobinuriaAcute Myelogenous LeukemiaAcute Lymphocytic LeukemiaMyelodysplastic SyndromeChronic Myelogenous LeukemiaChronic Lymphocytic LeukemiaHodgkin's LymphomaNon-Hodgkin's LymphomaMantle Cell LymphomaMultiple MyelomaWaldenstrom MacroglobulinemiaBreast CancerRenal Cell CarcinomaMelanomaSarcomaOvarian CancerThymoma

Keywords

Nonmyeloablative transplantAllogeneic transplantTransplant

Outcome Measures

Primary Outcomes (1)

  • Engraftment

    Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.

    One year

Secondary Outcomes (1)

  • Graft-versus-host disease

    One year

Study Arms (2)

Cladribine + melphalan

OTHER

Cladribine + melphalan conditioning

Procedure: Nonmyeloablative Allogeneic Transplant

TLI

OTHER

Total lymphoid irradiation conditioning

Procedure: Nonmyeloablative Allogeneic Transplant

Interventions

Nonmyeloablative Allogeneic TransplantPROCEDURE

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

Cladribine + melphalan

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +11 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Anemia, AplasticHemoglobinuria, ParoxysmalLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaMyelodysplastic SyndromesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Lymphocytic, Chronic, B-CellHodgkin DiseaseLymphoma, Non-HodgkinLymphoma, Mantle-CellMultiple MyelomaWaldenstrom MacroglobulinemiaBreast NeoplasmsCarcinoma, Renal CellMelanomaSarcomaOvarian NeoplasmsThymoma

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Failure DisordersBone Marrow DiseasesAnemia, HemolyticLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLymphomaNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms, Connective and Soft TissueEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Complex and MixedThymus NeoplasmsThoracic Neoplasms

Study Officials

  • Jeffrey W. Andrey, M.D.

    Scripps Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 10, 2011

Study Start

October 1, 2001

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 23, 2022

Record last verified: 2022-11

Locations

US(1)