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Closed (no longer recruiting)Last updated: 31 January 2024

NIVALLO: This phase I/II trial is testing the safety of an immunotherapy (Nivolumab) for patients whose blood cancer has relapsed following blood or bone marrow transplantationPilot study of the tolerability of nivolumab for relapsed or residual haematological malignancies after allogeneic haematopoietic stem cell transplantation

Clinical summary

Summary

All participants in this non-randomised trial will receive intravenous Nivolumab (3mg/kg) every two weeks for up to 48 weeks.

Conditions

This trial is treating patients with blood cancer.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

Trial Acronym

NIVALLO

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS),Melbourne Health

Scientific Title

Pilot study of the tolerability of nivolumab for relapsed or residual haematological malignancies after allogeneic haematopoietic stem cell transplantation

Eligibility

Inclusion

Age > 18 years
Prior allogeneic stem cell transplant for a haematological malignancy
Confirmed relapse or persistent haematological malignancy post allogeneic transplant
Immunosuppression cessation for minimum 2 weeks

Exclusion

Current evidence of any grade of GVHD
Prior history of grade 2 or higher acute GVHD
Moderate chronic GVHD within the previous 6 months or any prior history of severe chronic GVHD
Known autoimmune disease
Positive hepatitis B virus surface antigen
Positive hepatitis C virus antibody
Known HIV infection

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

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