Burkitt LymphomaPhase 1NCT03864419
Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda
A Phase 1 study testing Rituximab and Hyaluronidase Human, Cyclophosphamide and Vincristine in people with Burkitt Lymphoma and KSHV-associated Multicentric Castleman Disease, run by Fred Hutchinson Cancer Center at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Burkitt Lymphoma, KSHV-associated Multicentric Castleman Disease, Diffuse Large B-Cell Lymphoma
- What is being tested?
- Rituximab and Hyaluronidase Human, Cyclophosphamide and Vincristine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUganda
- Study dates
- 24 Oct 2019to 26 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histology and immunohistochemistry (CD20+) confirmed Burkitt lymphoma (BL), diffuse large B-cell lymphoma (DLBCL), or histology confirmed KSHV-associated multicentric Castleman disease with elevated blood KSHV viral load
- Cohort 1: Age should be equal to or greater than 15
- Cohort 2: Age: 2-15
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Able to provide informed consent (adults) or assent (children < 18 years) in English or Luganda
Show all 9Show fewer
- Human immunodeficiency virus (HIV)-infected patients eligible if meet the following criteria:
- CD4+ T-cell count > 200 cells/uL
- HIV treatable with effective antiretroviral therapy that does not include agents with known significant drug-drug interactions with accompanying chemotherapy (ritonavir and cobicistat contraindicated)
Who cannot join
- Previous therapy for lymphoma or KSHV-multicentric Castleman disease (MCD)
- History of hypersensitivity to rituximab
- Pregnant or nursing women. Men or women may not participate unless they have agreed to use effective contraception during treatment and for 12 months following completion of therapy
- Inadequate organ function, unless attributed to lymphoma or KSHV-MCD
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 times upper limit of normal
- Creatinine > 2 times upper limit than normal or calculated creatinine clearance < 60 mL/min
Show all 11Show fewer
- New York Heart Association (NYHA) cardiac failure class III or IV
- Patients with clinically significant anemia-hemoglobin less than 10 g/dL
- Central nervous system (CNS) masses consistent with lymphoma or untreated infection; leptomeningeal disease will not be excluded
- Patients with malignancy within 5 years, other than resected local skin cancer or limited Kaposi sarcoma (KS) (no known pulmonary KS)
- Patients with evidence of active infections including malaria and hepatitis B (participants with hepatitis B virus [HBV] controlled on antivirals will not be excluded)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With Local Standard-of-Care Chemotherapy for the Treatment of Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma or as Monotherapy for Kaposi Sarcoma Herpesvirus Associated Multicentric Castleman Disease in Pediatrics and Adults in Uganda
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.
Read the detailed description
OUTLINE:
Open-label Phase I study characterizing the safety, tolerability, and activity of subcutaneous rituximab hyaluronidase (sqR) alone (KSHV-MCD), or combined with local standard of care chemotherapy (BL or DLBCL), in 2 age-based cohorts of patients:
- Cohort 1: Age >= 15
- Cohort 2: Age: 2-14 sqR dose for Cohort 1 (adults) will be 1400 mg (flat dose); sqR dose for Cohort 2 (pediatrics) will depend on patient weight: >= 35 kg: 1400 mg, < 35 kg: 700 mg. For all participants, sqR will be administered with local standard of care chemotherapy (BL, DLBCL) or alone (KSHV-MCD), and supportive care.
Each cohort comprises two Therapy Groups. Therapy Group 1: up to 6 participants and will receive the first cycle of rituximab IV, and subsequent cycles as flat-dose sqR. Therapy Group 2: up to 12 participants and will receive flat-dose sqR for all cycles.
Disease-specific chemotherapy to be administered with rituximab hyaluronidase include:
PEDIATRIC BURKITT LYMPHOMA (BL): cyclophosphamide, vincristine and prednisone followed by 6 cycles of cyclophosphamide, vincristine, and methotrexate (COP-COM).
DLBCL: 6 cycles of cyclophosphamide, doxorubicin, vincristine and prednisone PO on days 1-5 of cycle 1 (CHOP).
ADULT BL: 6 cycles modified dose: etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone PO on days 1-5 (adjusted EPOCH).
KSHV-MCD: Rituximab or rituximab hyaluronidase SC on days 1, 8, 15, and 22.
After completion of study treatment, patients are followed up at 30 days, 3, 6, 9 and 12 months.
- Conditions
- Burkitt Lymphoma, KSHV-associated Multicentric Castleman Disease, Diffuse Large B-Cell Lymphoma
- Being tested
- Rituximab and Hyaluronidase Human, Cyclophosphamide, Vincristine, Methotrexate, Doxorubicin
- Medical subject headings
- Burkitt Lymphoma, Multi-centric Castleman's Disease, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab and Hyaluronidase HumanBiological
Also called Rituxan Hycela, Rituximab Plus Hyaluronidase, Rituximab/Hyaluronidase, Rituximab/Hyaluronidase Human
Given SC
CyclophosphamideDrug
Also called Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate
Given IV
VincristineDrug
Also called LEUROCRISTINE, VCR, Vincrystine
Given IV
MethotrexateDrug
Also called Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate
Given IV
DoxorubicinDrug
Also called Hydroxyl Daunorubicin, Hydroxyldaunorubicin
Given IV
Also called Adriamycine, Adriblastina, Doxolem, Doxorubicin.HCl
Given IV
PrednisoneDrug
Also called Deltacortene, Decorton, Decortisyl, DeCortin
Given PO
EtoposideDrug
Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Vepesid
Given IV
RituximabBiological
Also called BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort I (pediatric BL) | Experimental | Patients receive cyclophosphamide IV and vincristine IV on day 1, and prednisone IV or PO on days 1-7 in the absence of disease progression or unacceptable toxicity. Patients then receive rituximab IV or rituximab hyaluronidase SC, cyclophosphamide IV, vincristine IV, and methotrexate IV on day 1. Cycles repeat every 14 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Receives: Biological: Rituximab and Hyaluronidase Human; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Methotrexate; Biological: Rituximab |
| Cohort II (DLBCL) | Experimental | Patients receive rituximab IV or rituximab and hyaluronidase human SC, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, and prednisone PO on days 1-5 of cycle 1. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Receives: Biological: Rituximab and Hyaluronidase Human; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin; Drug: Doxorubicin Hydrochloride; Drug: Prednisone; Drug: Etoposide; Biological: Rituximab |
| Cohort III (Adult BL) | Experimental | Patients receive rituximab IV or rituximab and hyaluronidase human SC in day 1, etoposide IV, doxorubicin IV, and vincristine IV on days 1-4. Patients also receive cyclophosphamide IV on day 5 and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Receives: Biological: Rituximab and Hyaluronidase Human; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin; Drug: Doxorubicin Hydrochloride; Drug: Prednisone; Biological: Rituximab |
| Cohort IV (MCD) | Experimental | Patients receive rituximab IV or rituximab and hyaluronidase human SC on days 1, 8, 15, and 22 in the absence of disease progression or unacceptable toxicity. Receives: Biological: Rituximab and Hyaluronidase Human; Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Common Terminology Criteria for Adverse Events version 5.0 including unanticipated problems and grade 3-5 adverse events (AEs) at least probably related to subcutaneous rituximab hyaluronidase (sqR) administration.
Measured: Up to 12 months
Number of participants that result in sufficient pharmacodynamic criteria
Pharmacodynamic criteria is a Ctrough level above 25 ug/ml in children and adolescents after the first subcutaneous dose.
Measured: Up to 12 months
Secondary outcomes (4)
Number of participants achieving a repose of complete response (CR)
Response Evaluation Criteria in Solid Tumors (RECIST) criteria CR: complete disappearance of all target lesions.
Measured: 1 year
Overall survival
Kaplan-Meier estimate
Measured: 1 year
Progression-free survival
Kaplan-Meier estimate
Measured: 1 year
Disease-free survival
Kaplan-Meier estimate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start24 Oct 2019
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Why it stopped: Closed per SRC Low Accrual Policy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burkitt LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manoj Menon, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864419
- Sponsor's protocol ID
- RG1001799
- Other IDs
- U028, NCI-2019-01493, 10040
- Status last verified
- Dec 2023
- First submitted
- 1 Mar 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Menon MP, Ddungu H, Mubiru KR, Adams SV, Asea J, Namagembe R, Namuli P, Kambugu J, Towlerton AMH, Puronen C, Uldrick TS, Orem J, Warren EH. Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With CHOP Chemotherapy for the Treatment of Diffuse Large B-Cell Lymphoma in Uganda. JCO Glob Oncol. 2025 Apr;11:e2400489. doi: 10.1200/GO-24-00489. Epub 2025 Apr 4.
PubMed 40184567
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With Local Standard-of-Care Chemotherapy for the Treatment of Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma or as Monotherapy for Kaposi Sarcoma Herpesvirus Associated Multicentric Castleman Disease in Pediatrics and Adults in Uganda
- ClinicalTrials.gov ID
- NCT03864419
- Acronym / sponsor ID
- RG1001799
- Conditions
- Burkitt Lymphoma, KSHV-associated Multicentric Castleman Disease, Diffuse Large B-Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed per SRC Low Accrual Policy
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OUTLINE:
Open-label Phase I study characterizing the safety, tolerability, and activity of subcutaneous rituximab hyaluronidase (sqR) alone (KSHV-MCD), or combined with local standard of care chemotherapy (BL or DLBCL), in 2 age-based cohorts of patients:
- Cohort 1: Age >= 15
- Cohort 2: Age: 2-14 sqR dose for Cohort 1 (adults) will be 1400 mg (flat dose); sqR dose for Cohort 2 (pediatrics) will depend on patient weight: >= 35 kg: 1400 mg, < 35 kg: 700 mg. For all participants, sqR will be administered with local standard of care chemotherapy (BL, DLBCL) or alone (KSHV-MCD), and supportive care.
Each cohort comprises two Therapy Groups. Therapy Group 1: up to 6 participants and will receive the first cycle of rituximab IV, and subsequent cycles as flat-dose sqR. Therapy Group 2: up to 12 participants and will receive flat-dose sqR for all cycles.
Disease-specific chemotherapy to be administered with rituximab hyaluronidase include:
PEDIATRIC BURKITT LYMPHOMA (BL): cyclophosphamide, vincristine and prednisone followed by 6 cycles of cyclophosphamide, vincristine, and methotrexate (COP-COM).
DLBCL: 6 cycles of cyclophosphamide, doxorubicin, vincristine and prednisone PO on days 1-5 of cycle 1 (CHOP).
ADULT BL: 6 cycles modified dose: etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone PO on days 1-5 (adjusted EPOCH).
KSHV-MCD: Rituximab or rituximab hyaluronidase SC on days 1, 8, 15, and 22.
After completion of study treatment, patients are followed up at 30 days, 3, 6, 9 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort I (pediatric BL) | Experimental | Biological: Rituximab and Hyaluronidase Human, Drug: Cyclophosphamide, Drug: Vincristine, Drug: Methotrexate, Biological: RituximabPatients receive cyclophosphamide IV and vincristine IV on day 1, and prednisone IV or PO on days 1-7 in the absence of disease progression or unacceptable toxicity. Patients then receive rituximab IV or rituximab hyaluronidase SC, cyclophosphamide IV, vincristine IV, and methotrexate IV on day 1. Cycles repeat every 14 days for 6 cycles in the absence of disease progression or unacceptable toxicity. |
| Cohort II (DLBCL) | Experimental | Biological: Rituximab and Hyaluronidase Human, Drug: Cyclophosphamide, Drug: Vincristine, Drug: Doxorubicin, Drug: Doxorubicin Hydrochloride, Drug: Prednisone, Drug: Etoposide, Biological: RituximabPatients receive rituximab IV or rituximab and hyaluronidase human SC, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, and prednisone PO on days 1-5 of cycle 1. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. |
| Cohort III (Adult BL) | Experimental | Biological: Rituximab and Hyaluronidase Human, Drug: Cyclophosphamide, Drug: Vincristine, Drug: Doxorubicin, Drug: Doxorubicin Hydrochloride, Drug: Prednisone, Biological: RituximabPatients receive rituximab IV or rituximab and hyaluronidase human SC in day 1, etoposide IV, doxorubicin IV, and vincristine IV on days 1-4. Patients also receive cyclophosphamide IV on day 5 and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. |
| Cohort IV (MCD) | Experimental | Biological: Rituximab and Hyaluronidase Human, Biological: RituximabPatients receive rituximab IV or rituximab and hyaluronidase human SC on days 1, 8, 15, and 22 in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Histology and immunohistochemistry (CD20+) confirmed Burkitt lymphoma (BL), diffuse large B-cell lymphoma (DLBCL), or histology confirmed KSHV-associated multicentric Castleman disease with elevated blood KSHV viral load
- Cohort 1: Age should be equal to or greater than 15
- Cohort 2: Age: 2-15
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Key exclusion criteria (11 listed)
- Previous therapy for lymphoma or KSHV-multicentric Castleman disease (MCD)
- History of hypersensitivity to rituximab
- Pregnant or nursing women. Men or women may not participate unless they have agreed to use effective contraception during treatment and for 12 months following completion of therapy
- Inadequate organ function, unless attributed to lymphoma or KSHV-MCD
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 times upper limit of normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab and Hyaluronidase HumanAlso: Rituxan Hycela, Rituximab Plus Hyaluronidase, Rituximab/Hyaluronidase, Rituximab/Hyaluronidase HumanGiven SC | Biological | Cohort I (pediatric BL), Cohort II (DLBCL), Cohort III (Adult BL), Cohort IV (MCD) |
| CyclophosphamideAlso: Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrateGiven IV | Drug | Cohort I (pediatric BL), Cohort II (DLBCL), Cohort III (Adult BL) |
| VincristineAlso: LEUROCRISTINE, VCR, VincrystineGiven IV | Drug | Cohort I (pediatric BL), Cohort II (DLBCL), Cohort III (Adult BL) |
| MethotrexateAlso: Abitrexate, Alpha-Methopterin, Amethopterin, BrimexateGiven IV | Drug | Cohort I (pediatric BL) |
| DoxorubicinAlso: Hydroxyl Daunorubicin, HydroxyldaunorubicinGiven IV | Drug | Cohort II (DLBCL), Cohort III (Adult BL) |
| Doxorubicin HydrochlorideAlso: Adriamycine, Adriblastina, Doxolem, Doxorubicin.HClGiven IV | Drug | Cohort II (DLBCL), Cohort III (Adult BL) |
| PrednisoneAlso: Deltacortene, Decorton, Decortisyl, DeCortinGiven PO | Drug | Cohort II (DLBCL), Cohort III (Adult BL) |
| EtoposideAlso: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, VepesidGiven IV | Drug | Cohort II (DLBCL) |
| RituximabAlso: BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10Given IV | Biological | Cohort I (pediatric BL), Cohort II (DLBCL), Cohort III (Adult BL), Cohort IV (MCD) |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: Up to 12 months
Common Terminology Criteria for Adverse Events version 5.0 including unanticipated problems and grade 3-5 adverse events (AEs) at least probably related to subcutaneous rituximab hyaluronidase (sqR) administration.
Number of participants that result in sufficient pharmacodynamic criteria
Time frame: Up to 12 months
Pharmacodynamic criteria is a Ctrough level above 25 ug/ml in children and adolescents after the first subcutaneous dose.
4 secondary outcomes
Number of participants achieving a repose of complete response (CR)
Time frame: 1 year
Overall survival
Time frame: 1 year
Progression-free survival
Time frame: 1 year
Disease-free survival
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Closed per SRC Low Accrual Policy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 40184567Menon MP, Ddungu H, Mubiru KR, Adams SV, Asea J, Namagembe R, Namuli P, Kambugu J, Towlerton AMH, Puronen C, Uldrick TS, Orem J, Warren EH. Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With CHOP Chemotherapy for the Treatment of Diffuse Large B-Cell Lymphoma in Uganda. JCO Glob Oncol. 2025 Apr;11:e2400489. doi: 10.1200/GO-24-00489. Epub 2025 Apr 4.
- Individual participant dataSharing planned: No
Related trials for Burkitt Lymphoma
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 3
International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)
B-Cell Acute Lymphoblastic Leukaemia
RecruitingPhase 1/2
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
B-NHL, B-Non Hodgkin Lymphoma
Active, not recruitingPhase 1
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma, B-Cell Prolymphocytic Leukemia
Active, not recruitingPhase 2
Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas
ALK-Positive Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma Activated B-Cell Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoj Menon, MD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rituximab and Hyaluronidase Human, Cyclophosphamide and Vincristine in people with Burkitt Lymphoma and KSHV-associated Multicentric Castleman Disease, run by Fred Hutchinson Cancer Center at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Closed per SRC Low Accrual Policy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.