Two-Step Donor Stem Cell Transplant for Blood Cancers: Enhancing Cancer-Fighting Effects Safely

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03032783

This study is exploring a two-step approach to donor stem cell transplants for patients with high-risk blood cancers. The goal is to increase the cancer-fighting effects without adding extra side effects.

Patient Parameters

Program Overview

This phase II study is testing how well a donor stem cell transplant works for patients with high-risk blood cancers. Before the transplant, patients receive total-body irradiation and chemotherapy to stop the growth of both normal and cancerous cells in the bone marrow. This process also helps prevent the patient's immune system from rejecting the donor's stem cells. Once the healthy donor stem cells are infused, they can help the patient's bone marrow produce new blood cells and replace the patient's immune cells, potentially destroying any remaining cancer cells.

Description

The main goal of this study is to see if patients with high-risk blood cancers can have a better chance of survival two years after receiving a two-step donor stem cell transplant. Researchers are also looking at how often the cancer comes back within two years, the side effects of the treatment, and how well the new immune cells grow and recover.

Patients eligible for this study are those with high-risk blood cancers where a donor stem cell transplant is considered the best option for a cure. This includes patients whose cancer is stable or only slightly progressing after treatment, or those with untreated cancers where a transplant is the best chance for a cure. Patients must have a related donor whose immune markers are not a perfect match, and they must have good organ function and overall health.

The study will not include patients with certain health conditions, such as active brain cancer involvement, psychiatric disorders that prevent consent, or those who cannot tolerate the necessary treatments. Pregnant individuals or those unwilling to use contraception are also excluded.

Eligibility Criteria

Inclusion Criteria

  • Have a high-risk blood cancer where a donor stem cell transplant is the best option for a cure.
  • Cancer should be stable or only slightly progressing after treatment, or untreated but with high-risk features.
  • Have a related donor with mismatched immune markers.
  • Good organ function, including heart, lung, liver, and kidney health.
  • Overall good health with a performance status of 80% or higher.
  • Willing to use contraception if of childbearing potential.
  • Able to provide informed consent.
  • Aged 18 years or older.

Exclusion Criteria

  • Overall health performance status below 80%.
  • More than 5 points on the Hematopoietic Cell Transplant Co-Morbidity Index, unless approved by the study team.
  • HIV positive.
  • Active cancer involvement in the brain.
  • Psychiatric disorders preventing informed consent.
  • Pregnant or unwilling to use contraception if of childbearing potential.
  • Life expectancy of 6 months or less due to other health issues.
  • Recent treatment with certain medications like Alemtuzumab or ATG.
  • Unable to tolerate specific chemotherapy or radiation doses.

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