Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Antibodies

Antibodies, Monoclonal

Rituximab

Immunoglobulins

Antineoplastic Agents, Immunological

Immunologic Factors

375 mg/m2 rituximab by IV infusion weekly. The initial course of treatment is 4 weeks.

Subjects who achieve an objective response or stable disease after the initial course (4 weeks) were permitted to continue additional 4-week cycles of treatment, for 3 additional courses starting every 6 months (ie, at 6; 12; and 18 months).

Rituximab (biosimilar is Zytux) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B-cells. Rituximab destroys B-cells and is therefore used to treat diseases which are characterized by excessive numbers of B-cells, overactive B-cells, or dysfunctional B-cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders.

Ranjana H Advani, MD

Richard T Hoppe, MD

Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.

This study will evaluate the partial, complete, and overall response rates to rituximab of subjects with lymphocyte-predominant Hodgkin's lymphoma. Subjects will receive rituximab by IV infusion over several hours once a week for 4 weeks, followed by maintenance therapy as repeat course of the same dose and schedule rituximab at 6, 12, and 18 months.

This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.

Rituximab in Treating Patients With Hodgkin's Lymphoma

Phase 2 Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkin's Disease

PFS, assessed as the number of patients 5 years after treatment who are alive and without a ≥ 50% increase from nadir in the sum of the product of the greatest lesion diameters (SPD) of any previously-identified abnormal node, or appearance of any new lesion

OS, assessed as the number of patients 5 years after treatment who are alive

Overall response as assessed as Complete Response (CR) + Partial Response (PR)

* CR was determined as complete metabolic response (CMR), meaning complete resolution of 18-fluorodeoxyglucose (FDG) uptake within the tumor volume so that it is indistinguishable from surrounding normal tissue.
* PR was determined as partial metabolic response (PMR), meaning reduction of greater than 25% in the standardized uptake value (SUV) adjusted for body surface area (SUV-BSA). A reduction in the extent of tumor FDG uptake is not required for PMR.

Genentech, Inc.

Ranjana Advani

Saul A. Rosenberg, MD, Professor of Lymphoma

Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months for 2 years.

This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.

Rituximab 375 mg/m2 Per Week

Rituximab 375 mg/m2 per week by IV infusion for 4 consecutive weeks

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.

Ranjana Advani, MD, Professor of Lymphoma

Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks every 6 months, for up to 4 treatment cycles

Progression-free Survival (PFS)

Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks

Overall Survival (OS)

Overall Response (CR+PR)

Complete Response

Partial Response

375 mg/m2 rituximab by IV infusion weekly, assessed after 4 weeks of treatment

Overall Response Rate (ORR)

Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months

Initial Group of participants prior to the addition of the three extra cycle treatments.

Rituximab 375 mg/m2 Per Week Inital Group

Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months

Secondary Group of participants were added after the addition of the three extra cycle treatments.

Rituximab 375 mg/m2 Per Week Secondary Group

Cycle 1 (Initial Treatment)

Cycle 2 (Maintenance Treatment)

Cycle 3 (Maintenance Treatment)

Cycle 4 (Maintenance Treatment)

Anti-Infective Agents

Bleomycin

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Brentuximab Vedotin

Vinblastine

Dacarbazine

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Immunotoxins

Immunoconjugates

Tubulin Modulators

Antimitotic Agents

After 2 ABVD cycles an interim PET-2 will be performed, and treatment will be adapted according to to PET results

PET-2 negative patients will be treated with 4 cycles of ACVD (Adriamycin, Cyclophosphamide, Vinblastine And Dacarbazine)

After 2 ABVD cycles an interim PET-2 will be performed, and treatment will be adapted according to to PET results

PET-2 positive patients will be treated with 4 cycles of ACVD with addition of Brentuximab Vedotin

25mg/m2 Bolus injection via fast running drip of 0.9% NaCl in days 1 and 15 of each 28 day cycle.

Adriamycin

400mg/m2 Infusion in 500ml sodium chloride 0.9%over 30min. in days 1 and 15 of each 28 day cycle

6mg/m2 Intravenous infusion in 50ml sodium chloride 0.9% over 10 minutes, in days 1 and 15 of each 28 day cycle

375mg/m2 Infusion in 500mls 0.9% NaCI over least 60mins. in days 1 and 15 of each 28 day cycle

1.2mg/kg Intravenous infusion, in days 1 and 15 of each 28 day cycle

All enrolled patients receive 2 cycles of ABVD (Adriamycin 25mg/m2, Bleomycin10,000units/m2, Vinblastine 6mg/m2 and Dacarbazine 375mg/m2)

ABVD

Ayman Alhejazi, MD

Ayman Hejazi, MD

This is a prospective, multi-center, open-label, phase II clinical trial, aims to assess the effectiveness of the combination ACVD (Adriamycin, Cyclophosphamide, Vinblastine and Dacarbazine) and BV (Brentuximab Vedotin) in PET-2 positive advanced-stage HL patients, in order to improve the overall long-term disease control in the entire cohort of advanced-stage HL.

With the aim of reducing Blemoycin pulmonary injury (BPI) , Bleomycin was withdrawn and substituted with Cyclophosphamide (ACVD cycle) in patients with a PET-2 negative. All advanced stage HL patients will receive 2 cycles of the standard treatment ABVD and assessed with PET-2 scan.

Knowing that Cyclophosphamide toxicities include cytopenias, amenorrhea and male infertility. These toxicities are mainly dependent on the total cumulative dose. Doses less than 4 g/m2 are not associated with sterility or major toxicity, doses higher than this can lead to azoospermia which was reversible in many cases therefore the cumulative dose will be used in this study is 3200 mg. Additionally, Brentuximab Vedotin has shown significant activity in relapsed refractory HL with minor toxicities.

PET scan after 2 cycles of ABVD has proven to be an excellent tool to identify patients that will have long term PFS of 95% when it is negative and only progression-free survival (PFS) of less than 15% when it is positive.

The primary endpoint of the study will be to assess the overall 3-Y PFS of the entire cohort of patients.

OPTmizing Advanced Stage HodgkIn LymphoMa patIentS Therapy

A Phase II, Multicenter, Open Label Study of Treatment Intensification With ACVD and Brentuximab-Vedotin in Advanced-stage Hodgkin Lymphoma Patients With a Positive Interim PET Scan After 2 ABVD Cycles

The ability of ACVD to reduce lung toxicity as compared to ABVD by performing a pulmonary function test (PFT) at baseline and end of treatment

The feasibility of the entire program in terms of grade 3 or 4 NCICTCAE or WHO toxicity

PFS is estimated from the date of diagnosis until the date of first disease progression or relapse, death for any cause.

Superior overall 3 year progression-free survival of patients with PET 2 positive after 2 cycles of ABVD with ACVD and BV compared to historical control of ABVD treated patients and PET 2 negative patients with ACVD only after 2 cycles of ABVD.

Superior overall survival of PET 2 positive patients treated with ACVD + BV after 2 cycles of ABVD and PET 2 negative treated with ACVD after 2 cycles of ABVD. It is estimated from the date of diagnosis up to study completion or death, whichever came first, assessed up to 5 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Rituximab in Treating Patients With Hodgkin's Lymphoma	NCT00003820	Lymphoma Hodgkin Lymphom... Nodular Lymphoc...	Rituximab	3 Years -	Stanford University
OPTmizing Advanced Stage HodgkIn LymphoMa patIentS Therapy	NCT03527628	Classical Hodgk... Hodgkin Lymphom... Hodgkin Disease Hodgkin Lymphom...	Adriamycin Cyclophosphamid... Vinblastine Dacarbazine Brentuximab Ved... ABVD	14 Years - 60 Years	King Abdullah International Medical Research Center

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