NCT01282216

Brief Summary

This research is being done to understand the effects of certain types of bone marrow transplant (BMT) on the immune system. Your doctors are planning a BMT, using one of your family members as the bone marrow donor, for your cancer. Part of that BMT involves a chemotherapy drug, called Cyclophosphamide (Cytoxan), given after the transplant. This research is being done to understand the effects of Cyclophosphamide on the immune system.

Trial Health

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Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_2

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

First Submitted

Initial submission to the registry

January 13, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 30, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

4.8 years

First QC Date

January 13, 2011

Results QC Date

May 8, 2019

Last Update Submit

May 8, 2019

Conditions

Transplant-Related Cancer

Outcome Measures

Primary Outcomes (1)

  • T-cell Immunity Augmentation

    Number of participants in which patient-donor pairs were not pre-immune to hepatitis A or CRM197, show augmented T-cell immunity when the vaccine is also given to the bone marrow donor.

    up to 6 months

Secondary Outcomes (2)

  • Recipient Vaccine-specific T-cell Response Post-transplant, Before Vaccination

    up to 6 months

  • Recipient Vaccine-specific T-cell Response After Post-transplantation Vaccine

    up to 6 months

Study Arms (3)

Donor PCV13

ACTIVE COMPARATOR

Donors receive PCV13 prior to bone marrow donation.

Biological: PCV13

Donor Havrix

ACTIVE COMPARATOR

Donors receive Havrix prior to bone marrow donation.

Biological: Havrix

Recipient vaccine

ACTIVE COMPARATOR

Recipients receive Havrix and PCV13 post bone marrow transplant.

Biological: HavrixBiological: PCV13

Interventions

HavrixBIOLOGICAL

1440 ELISA units, or 1 mL, IM

Also known as: Hepatitis A vaccine
Donor HavrixRecipient vaccine
PCV13BIOLOGICAL

0.5 mL IM

Also known as: Prevnar-13
Donor PCV13Recipient vaccine

Eligibility Criteria

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

You may qualify if:

  • Patient age \> 18 years.
  • Plan to undergo one of the following types of transplant, using bone marrow from a related donor:
  • Myeloablative, HLA matched or partially HLA-mismatched (haploidentical), related-donor bone marrow transplantation that includes high-dose posttransplantation Cy
  • Nonmyeloablative, HLA matched or partially HLA-mismatched, related-donor bone marrow transplantation that includes high-dose posttransplantation Cy Note: Patients who receive posttransplantation rituximab are eligible.
  • Receipt of the type of myeloablative or nonmyeloablative BMT
  • The bone marrow donor has received the pre-bone marrow harvest vaccine (either Prevnar or hepatitis A vaccine) on this study.
  • \. Donor age \> 18 years.

You may not qualify if:

  • Hypersensitivity to either the components of hepatitis A vaccine (including neomycin) or the components of the PCV7 and PCV13 vaccines (including diphtheria toxin).
  • Severe latex allergy.
  • Graft failure.
  • Disease progression or relapse, or disease persistence requiring treatment.Note: Patients with asymptomatic or low-volume disease progression or relapse may be eligible, determined on a case-by-case basis by the PI.
  • Systemic immunosuppression for GVHD treatment or prophylaxis within 4 weeks (+/- 5 days) prior to vaccination.
  • Pregnant or breastfeeding
  • Hypersensitivity to both the components of hepatitis A vaccine (including neomycin) and the components of the PCV7 and PCV13 vaccines (including diphtheria toxin).
  • Severe latex allergy.
  • Expected to be on systemic immunosuppressants between the time of vaccination and the bone marrow donation.
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Interventions

Hepatitis A Vaccines

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Rich Ambinder, MD
Organization
Johns Hopkins University
rambind1@jhmi.edu
4109558839

Study Officials

  • RIchard Ambinder, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Only the study pharmacist was unblinded.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2011

First Posted

January 24, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 30, 2019

Results First Posted

May 30, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)