NCT01685606

Brief Summary

The study of whether an infusion of blood cells called lymphocytes from a donor can stimulate the immune system to fight your leukemia/lymphoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
25 days until next milestone

Results Posted

Study results publicly available

June 26, 2015

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

2.3 years

First QC Date

September 12, 2012

Results QC Date

June 4, 2015

Last Update Submit

February 23, 2022

Conditions

Mantle Cell LymphomaDiffuse Large Cell LymphomaBurkitts LymphomaT Cell LymphomasAcute Myeloid Leukemia/Acute Lymphoblastic Leukemia

Keywords

LeukemiaLymphomaMantle cellDLBCLDLBCDiffuse large B cellT cellAMLALL

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate of Cellular Immune Therapy With HLA Haploidentical Peripheral Blood Pheresed Cells in Patients With Relapsed/Refractory Hematological Malignancies.

    Criteria for AML and ALL (adapted from Cheson et al.20) Complete remission (CR) is defined as the presence of all of the following * Peripheral blood o No leukemic blasts present. * No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement) * Bone marrow * Cellularity \>20% with baseline maturation. * No Auer rods * Less than 5% blast cells. * Complete blood counts and bone marrow normalization criteria must be met within one week of each other. Hematopoeitic recovery is an ANC \> 1.0 x 109/L and platelet count \> 100x109/L. No specific hemoglobin or hematocrit level is specified but the patient must be transfusion free. Complete remission with incomplete recovery (CRi) is defined as the following: * Meets criteria for CR except * ANC \< 1.0 x 109/L or platelet count \< 100x109/L Partial remission (PR). • Must meet all criteria of a CR except that the bone marrow may contain 5-20% blasts.

    8 weeks after infusion then 6 months after and every 4 months for approximately 2 years

Secondary Outcomes (1)

  • To Evaluate the Rate of Dose Limiting Toxicities of HLA Haploidentical Peripheral Blood Pheresed Cellular Infusions.

    30 days and 16 weeks after infusion

Study Arms (1)

cellular immunotherapy

EXPERIMENTAL

A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.

Biological: cellular immunotherapy

Interventions

cellular immunotherapyBIOLOGICAL

A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.

cellular immunotherapy

Eligibility Criteria

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

You may qualify if:

  • Histologic confirmation of hematological malignancy consisting of the following leukemias/lymphomas:
  • Mantle cell lymphoma with Ki-67\>30%
  • Diffuse Large Cell Lymphoma
  • Burkitts Lymphoma
  • Systemic T Cell Lymphomas
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Recurrence or progression of hematological malignancy after at least 1 prior standard treatment with progression within 6 months from last treatment.
  • No curative treatment option is available.
  • \> 4-weeks since prior chemotherapy or radiation to cellular therapy infusion. (Hydroxyurea may be utilized up to 48 hours prior to initiation of treatment on this protocol).
  • Age equal to or greater than 18 years.
  • Patients with a history of invasive second malignancy unless disease free for \> 5 years.
  • Patients must have an expected life expectancy of at least 2 months at the time of initiation of treatment.
  • No active systemic infection.

You may not qualify if:

  • DLCO \> 40% with no symptomatic pulmonary disease.
  • LVEF \> 40% by MUGA or echocardiogram.
  • Creatinine \< 2.0 mg/dl. Total bilirubin less than 1.5x the upper limit of normal (ULN), AST \< 3x ULN.
  • Non-pregnant and willing to use appropriate birth control during the duration of the study period.
  • Evidence of HIV infection.
  • Any uncontrolled severe, concurrent illness which in the opinion of the treating physician would make this protocol treatment unreasonably hazardous for the patient.
  • Oxygen dependent obstructive pulmonary disease.
  • Failure to demonstrate adequate compliance with medical therapy and follow-up.
  • Significant medical or psychiatric illness that would impair the ability to participate in protocol therapy.
  • For women of reproductive potential, refusal to use effective form of contraception.
  • Previous allogeneic stem cell transplant
  • Patients who have had previous purine analog (fludarabine, pentostatin, 2-CDA) -Patients with chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), multiple myeloma, and indolent lymphoma (follicular lymphoma, marginal zone lymphoma)
  • Patients with HLA antibodies to donor HLA type.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Reagan JL, Fast LD, Safran H, Nevola M, Winer ES, Castillo JJ, Butera JN, Quesenberry MI, Young CT, Quesenberry PJ. Cellular immunotherapy for refractory hematological malignancies. J Transl Med. 2013 Jun 19;11:150. doi: 10.1186/1479-5876-11-150.

    PMID: 23782682DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-CellLymphoma, Large B-Cell, DiffuseBurkitt LymphomaLymphoma, T-CellLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemiaLymphoma

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, MyeloidHematologic DiseasesLeukemia, Lymphoid

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Results Point of Contact

Title
Dr. Peter Quesenberry
Organization
Brown University Oncology Research Group (BrUOG)
kayla_rosati@brown.edu
4018633000

Study Officials

  • Peter Quesenberry, MD

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 14, 2012

Study Start

March 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 4, 2022

Results First Posted

June 26, 2015

Record last verified: 2022-02

Locations

US(2)