Phase 2
Completed N=20
Radiolabeled Monoclonal Antibody and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With High-Risk Lymphoid Malignancies
Source: ClinicalTrials.gov NCT01921387 ↗Enrolled (actual)
20
Serious AEs
100.0%
Results posted
Sep 2018
Primary outcomePrimary: Maximum-tolerated Dose (MTD) of Yttrium-90-BC8-DOTA — 34 Gy - MTD
Summary
This phase I/II trial studies the side effects and the best dose of radiolabeled monoclonal antibody when given together with combination chemotherapy before stem cell transplant and to see how well it works in treating patients with high-risk lymphoid malignancies. Radiolabeled monoclonal antibodies, such as yttrium Y 90 anti-CD45 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving chemotherapy before a stem transplant stops the growth of cancer cells by stopping them from dividing or killing them. Stem cells collected from the patient's blood are then returned to the patient to replace the blood-forming cells that were destroyed by the radiolabeled monoclonal antibody and chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum-tolerated Dose (MTD) of Yttrium-90-BC8-DOTA |
34 | — |
| PRIMARY Progression-free Survival Following Autologous Stem Cell Transplant (ASCT) |
12 | — |
| SECONDARY Estimated Dose to Tumor Sites Based on the Tumor to Normal Organ Ratios Derived From Dosimetry Estimates Coupled With the Absorbed Dose to Normal Organs Based on the Administered Activity of Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8 |
52.8 | — |
| SECONDARY The Lowest Antibody (Yttrium 90-BC8-DOTA) Dose (mg/kg) That is Consistent With a Favorable Biodistribution Rate >= 80% in Lymphoma Patients |
0.75 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have a histologically confirmed diagnosis of B-NHL, T-NHL, or HL; only patients with classical HL must have documented histologic demonstration of CD45+ cells adjacent to the Reed Sternberg cells; patients must have received at least one prior standard systemic therapy with documented recurrent or refractory disease; patients with mantle cell lymphoma (MCL), T-NHL, or other high-risk malignancies may be enrolled/transplanted in complete remission (CR)/first partial remission (PR1)
- Creatinine = 2 x10^6 CD34/kg autologous hematopoietic stem cells harvested and cryopreserved
- Patients must have an expected survival of > 60 days and must be free of major infection
Exclusion Criteria
- Circulating human anti-mouse antibody (HAMA), to be determined before each infusion
- Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled therapy dose with the exception of rituximab
- Inability to understand or give an informed consent
- Lymphoma involving the central nervous system
- Other serious medical conditions considered to represent contraindications to ASCT (e.g., abnormally decreased cardiac ejection fraction, diffusion capacity of carbon monoxide [DLCO] 20 gray (Gy) to a critical organ within 1 year of enrollment
- Southwestern Oncology Group (SWOG) performance status >= 2.0
Data sourced from ClinicalTrials.gov (NCT01921387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.