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NCT03864419
Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda
Phase 1 trial testing Rituximab and Hyaluronidase Human in Burkitt Lymphoma in 18 participants. Terminated before completion.
26 July 2023
Quick facts
| Lead sponsor | Fred Hutchinson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 24 October 2019 |
| Primary completion | 26 July 2023 |
| Estimated completion | 26 July 2023 |
| Sites | 1 location across Uganda |
Drugs / interventions tested
- Rituximab and Hyaluronidase Human
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Vincristine (vincristine) — full drug profile →
- Methotrexate
- Doxorubicin
- Doxorubicin Hydrochloride — full drug profile →
- Prednisone (prednisone) — full drug profile →
- Etoposide
- Rituximab — full drug profile →
Conditions studied
- Burkitt Lymphoma — all drugs for Burkitt Lymphoma →
- KSHV-associated Multicentric Castleman Disease — all drugs for KSHV-associated Multicentric Castleman Disease →
- Diffuse Large B-Cell Lymphoma — all drugs for Diffuse Large B-Cell Lymphoma →
Sponsor
Fred Hutchinson Cancer Center — full company profile →
Who can join
2 and older, any sex, with Burkitt Lymphoma or KSHV-associated Multicentric Castleman Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial studies how well rituximab hyaluronidase and combination chemotherapy work in treating patients in Uganda with Burkitt lymphoma, diffuse large B-cell lymphoma, or Kaposi sarcoma herpesvirus associated multicentric Castleman disease. Rituximab hyaluronidase is a combination of rituximab and hyaluronidase. Rituximab binds to a molecule called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Hyaluronidase allows rituximab to be given by injection under the skin. Giving rituximab and hyaluronidase by injection under the skin is faster than giving rituximab alone by infusion into the blood. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, methotrexate, etoposide, doxorubicin, and prednisone work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. While rituximab has a clear survival benefit in patients within developed countries, differences in supportive care and infectious co-morbidities require special attention. Giving rituximab hyaluronidase alone or in combination with chemotherapy may work better in treating patients with Burkitt lymphoma, diffuse large B-cell lymphoma, or Kaposi sarcoma herpesvirus associated multicentric Castleman disease compared to chemotherapy alone in Uganda.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Immune Microenvironment in Childhood Cancers: Characteristics and Therapeutic Challenges.
Pathania AS. · · 2024 · cited 9× · PMID 38927907 · DOI 10.3390/cancers16122201
Verify or expand the search:
- PubMed search for NCT03864419
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03864419 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fred Hutchinson Cancer Center
- Last refreshed: 3 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03864419.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing