Brief Summary

RATIONALE: Giving low-dose total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant after total-body irradiation and to see how well it works in treating patients with relapsed or refractory hematologic cancer or acute myeloid leukemia or acute lymphocytic leukemia in complete remission.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_1 leukemia

Timeline

Completed

Started Oct 2009

Shorter than P25 for phase_1 leukemia

Geographic Reach

1 country

1 active site

Status

terminated

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

2.1 years study duration

Study Start

First participant enrolled

October 1, 2009

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed

Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

2.1 years

First QC Date

October 15, 2009

Last Update Submit

September 13, 2013

Conditions

Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)recurrent adult acute myeloid leukemiaadult acute myeloid leukemia in remissionrecurrent adult acute lymphoblastic leukemiaadult acute lymphoblastic leukemia in remissionrelapsing chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiarefractory chronic lymphocytic leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromeschronic myelomonocytic leukemiarecurrent adult diffuse large cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult T-cell leukemia/lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromeadult nasal type extranodal NK/T-cell lymphomaperipheral T-cell lymphomahepatosplenic T-cell lymphomaanaplastic large cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomarecurrent adult Hodgkin lymphomarefractory multiple myelomachildhood acute myeloid leukemia in remissionrecurrent childhood acute myeloid leukemiachildhood acute lymphoblastic leukemia in remissionrecurrent childhood acute lymphoblastic leukemiachildhood diffuse large cell lymphomarecurrent childhood large cell lymphomaBurkitt lymphomachildhood immunoblastic large cell lymphomaangioimmunoblastic T-cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood anaplastic large cell lymphomarecurrent childhood grade III lymphomatoid granulomatosisrecurrent childhood small noncleaved cell lymphomachildhood nasal type extranodal NK/T-cell lymphoma

Outcome Measures

Primary Outcomes (1)

Toxicity
3 years

Secondary Outcomes (3)

Immunologic parameters before and after haploidentical therapy
3 years
Anti-tumor activity and/or duration of remission in those patients who enter the study in second complete remission or greater
3 years
Treatment-related mortality
3 years

Study Arms (1)

Irradiated allogeneic lymphocytes after Total Body Irradiation

EXPERIMENTAL

Biological: Irradiated haploidentical allogeneic lymphocytesRadiation: total-body irradiation

Interventions

Irradiated haploidentical allogeneic lymphocytesBIOLOGICAL

Partially HLA-matched irradiated donor lymphocytes will be infused after total body irradiation.

Irradiated allogeneic lymphocytes after Total Body Irradiation

total-body irradiationRADIATION

100 cGy TBI

Irradiated allogeneic lymphocytes after Total Body Irradiation

Eligibility Criteria

Age13 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Patients over 18 years old must meet the following criteria: * Histologically confirmed hematologic malignancy and not a candidate for a standard allogeneic transplantation * High-risk disease, including: * Refractory/relapsed acute myeloid leukemia (AML) or AML in second or greater completion remission (CR2) * Relapsed or refractory acute lymphoblastic leukemia (ALL) or ALL in CR2 * Tyrosine kinase inhibitor-resistant chronic myelogenous leukemia in chronic, accelerated, or blast crisis * Fludarabine-resistant chronic lymphocytic leukemia * High-risk myelodysplastic syndrome (MDS) (i.e., MDS with a score ≥ 1.5 by the International Scoring System) * Chronic myelomonocytic leukemia * Relapsed diffuse large cell non-Hodgkin lymphoma (NHL) with measurable disease after (or not eligible for) high-dose chemotherapy/autologous hematopoietic stem cell (HSC) rescue or allogeneic hematopoietic stem cell transplantation (HSCT) * Relapsed follicular NHL, mantle cell lymphoma, or low-grade histology NHL with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT * Relapsed or refractory high-grade/aggressive NHL (Burkitt lymphoma, lymphoblastic lymphoma, T-cell lymphoma, NK-like lymphoma) with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT * Hodgkin lymphoma with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT * Relapsed or refractory multiple myeloma after (or not eligible for) high-dose chemotherapy/autologous HSC rescue and following salvage therapy with thalidomide, lenalidomide, bortezomib or other FDA-approved multiple myeloma salvage therapies * Patients 13-17 years old must meet the following criteria: * Histologically confirmed hematologic malignancy and not a candidate for a standard allogeneic transplantation * High-risk disease, including: * Refractory/relapsed AML or AML in CR2 * Relapsed or refractory ALL or ALL in CR2 * Relapsed diffuse large cell NHL with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT * Relapsed follicular NHL, mantle cell lymphoma (or low-grade histology NHL) with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT * Relapsed or refractory high-grade/aggressive NHL (Burkitt lymphoma, lymphoblastic lymphoma, T-cell lymphoma, NK-like lymphoma) with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT * Hodgkin lymphoma with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT * Eligible for haploidentical irradiated cellular therapy * No known active brain metastases or malignant meningitis * Available partially (≥ 3/6 class I antigen) HLA-matched (by serology) related donor NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 * Karnofsky PS 60-100% (for patients \> 16 years) or Lansky PS 60-100% (for patients ≤ 16 years) * Patients who are unable to walk because of paralysis but who are up in a wheelchair will be considered ambulatory for the purpose of assessing PS * Patients ≥ 18 years: * Total bilirubin \< 1.5 times upper limit of normal (ULN) (unless attributable to Gilbert disease) * DLCO/alveolar volume \> 50% * Serum creatinine \< 2.0 mg/dL * Patients 13-17 years: * Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows: * 13 to \< 16 years: 1.5 mg/dL (male) or 1.4 mg/dL (female) * ≥ 16 years: 1.7 mg/dL (male) or 1.4 mg/dL (female) * AST/ALT ≤ 2.5 times ULN for age * Total bilirubin \< 2.0 mg/dL (unless attributable to Gilbert syndrome) * Shortening fraction ≥ 27% by ECHO or ejection fraction ≥ 50% by radionuclide angiogram * FEV\_1, forced vital capacity, and DLCO corrected for hemoglobin ≥ 60% by pulmonary function tests (PFTs) * Children unable to cooperate for PFTs must meet the following criteria: * No evidence of dyspnea at rest * No exercise intolerance * No requirement for supplemental oxygen therapy * Any other organ dysfunction thought to be secondary to disease will be considered separately and the patient will be eligible at the physician's discretion * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception before, during, and for 24 weeks after study treatment * No known HIV positivity * No history of current or prior medical problems that, in the investigator's opinion, would prevent administration of study treatment or assessment of response due to excess toxicity * No active uncontrolled infections or other medical, psychological, or social conditions that might increase the likelihood of patient adverse effects or poor outcomes PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No corticosteroids within 2 weeks before receiving irradiated donor lymphocyte infusion * No medications that might increase the likelihood of patient adverse effects or poor outcomes

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

University of Medicine and Dentistry of New Jerseylead
National Cancer Institute (NCI)collaborator

Study Sites (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesCongenital AbnormalitiesLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseBlast CrisisLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myelomonocytic, ChronicLymphoma, Large B-Cell, DiffuseLymphoma, FollicularLymphoma, Mantle-CellLymphoma, Non-HodgkinLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large-Cell, ImmunoblasticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLymphoma, Extranodal NK-T-CellLymphoma, T-Cell, PeripheralLymphoma, Large-Cell, AnaplasticHodgkin DiseaseDendritic Cell Sarcoma, InterdigitatingImmunoblastic Lymphadenopathy

Interventions

Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidLeukemia, LymphoidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, B-CellMyelodysplastic-Myeloproliferative DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, T-CellHistiocytic Disorders, MalignantHistiocytosisLymphadenopathy

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsInvestigative Techniques

Study Officials

Roger Strair, MD, PhD
Rutgers Cancer Institute of New Jersey
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 16, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

US(1)

Study Stopped

Partially HLA-Matched Irradiated Allogeneic Cellular Therapy After Reduced Intensity Total Body Irradiation

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Irradiated allogeneic lymphocytes after Total Body Irradiation

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Irradiated allogeneic lymphocytes after Total Body Irradiation

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations