Treating High Risk Leukemia With CD40 Ligand & IL-2 Gene Modified Tumor Vaccine

Plain-language summary

This study examined a tumor vaccine genetically modified with CD40 ligand and IL-2 in patients with high-risk leukemia. Patients aged 75 and under with lymphoid or acute myeloid leukemia or myelodysplastic syndrome who were at high risk of relapse could take part. The study was carried out in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Baylor College of Medicine

Intervention

Dose Level 1, Dose Level 2, Dose Level 3

Start date

6/1/1999

Estimated completion

6/1/2010

Countries

United States

Related genes

Locations

• Houston, United States
• Houston, United States
• Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Patients less than or equal to 75 years old with lymphoid (pre-B, B, T, non B-, non T, or Burkitt if bone marrow blasts \> 20%) or acute myeloid leukemia (M0 to M7) or myelodysplastic syndrome and with: Disease that has entered remission with chemotherapy and/or bone marrow transplantation, but is considered to be at high risk of relapse. or Primary, or relapsed treatment-refractory disease who, at the time of reinjection of the tumor vaccine, are at a state of complete or partial cytological remission disease (\<20% blasts infiltrating the bone marrow) after a second/higher line of conventional and/or high dose chemotherapy.
2. Patients must have a life expectancy of at least 10 weeks.
3. Patients must have ECOG performance status of 0-2 as below:
4. Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study, and have an absolute neutrophil count \>500/mm3, absolute lymphocyte count \>200/mm3, and platelet count \>50,000/mm3.
5. Patients must not have active GvHD at the time of protocol entry.
6. Patient has not received high dose steroids within the last week or other immunosuppressive drugs within a week (or longer as indicated by the half life of the agent)
7. Patients must not be infected at time of protocol entry, and should not be receiving antibiotics (other than prophylactic Septra.)
8. Patients must not be HIV-positive.
9. Patients must have adequate liver function (bilirubin\<1.5 mg% SGOT\<2x normal, normal prothrombin time).
10. Patients must have transduced cells available that are demonstrably \>20% CD40L expressing fibroblasts and producing\>150 pg IL-2/10 6 cell/24 hr.
11. Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
12. Patient must not have received treatment with other investigational agents within the last 4 weeks.
13. Patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom.

Exclusion Criteria:

1. Rapidly progressive/refractory disease (\>20% blasts infiltrating the bone marrow)
2. Life expectancy \< 10 weeks
3. Active infection
4. Need for concomitant drugs except analgesics
5. Pregnancy or lactation
6. Seropositive for HIV