Clinical trial NCT04026269: Clinical Efficacy of MOAP Regimen for Relapsed/Refractory cHL as a Rescue Therapy After DP Regimen
Official title: Clinical Efficacy of MOAP Regimen for Relapsed/Refractory Classical Hodgkin's Lymphoma as a Rescue Therapy After Ineffective Treatment of Additional Low-dose Decitabine to Anti-PD-1 Antibody Camrelizumab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hodgkin Lymphoma
Keywords: MOAP; Relapsed/Refractory; Hodgkin Lymphoma; DP;
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The DP regimen, low-dose decitabine combined with SHR-1210, is the new treatment for relapsed or refractory classical Hodgkin's Lymphoma. Though the CR rate of this regimen is impressively high, which is verified more than 70% in our I/II phase study, there are also lots of patients cannot benefit from this treatment. On top of that, as the increasing utilization of mono-therapy or combination treatment with the immune checkpoint blockade (ICB), the adverse reactions associated with immunotherapy make it unavailable in parts of patients. The application of MOAP regimen to patients, who have a progressive disease after DP regimen, can bring high CR rate. MOAP can be the a rescue treatment for cHL resisted to DP treatment.


Eligibility criteria: Inclusion Criteria:

1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
2. 13 to 70 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
6. Subjects must have received at least two prior chemotherapy regimen and four cycle of DP regimen, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
7. Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Primary outcomes:
measure: CRR assess by investigators per the 2014 Lugano classification
timeFrame: 3 years
measure: Number of Subjects with treatment-related adverse events (AEs)
timeFrame: 2 years
measure: duration of CR
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Biotherapeutic Department of Chinese PLA General Hospital
state: Beijing
Study officials:
References: