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One-arm, two-stage clinical study for cladribine combined with G-CSF, low-dose cytarabine and peminase (C-GAP) in the treatment of relapsed refractory acute lymphoblastic leukemia/lymphocytic lymphoma

One-arm, two-stage clinical study for cladribine combined with G-CSF, low-dose cytarabine and peminase (C-GAP) in the treatment of relapsed refractory acute lymphoblastic leukemia/lymphocytic lymphoma

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800020344
Enrollment
Unknown
Registered
2018-12-25
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALL

Interventions

Sponsors

Department of Hematology, Cancer Center, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, relapsed/refractory ALL (except Ph+ALL), the classification diagnosis refers to the French-American collaborative group diagnostic criteria (FAB standard) and the World Health Organization diagnostic criteria (WHO2008 standard); 2. Aged 15-70 years old, general condition is available, the Eastern Oncology Collaborative Group Physical Status Assessment (ECOG-PS) score = 3 points.

Exclusion criteria

Exclusion criteria: 1. There are severe heart, kidney or liver dysfunction; serum direct bilirubin, indirect bilirubin, alanine aminotransferase, aspartate aminotransferase, serum creatinine 2 times higher than the normal high limit; heart function level II or above; 2. Patients with other malignant tumors need to be treated.

Design outcomes

Primary

MeasureTime frame
OS, RFS;

Countries

China

Contacts

Public ContactLu Yue

Department of Hematology, Cancer Center, Sun Yat-sen University

lvyue@sysucc.org.cn+86 13925084058

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026