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Recombinant human thrombopoietin (rhTPO) combined with granulocyte colony stimulating factor (G-CSF) for autologous peripheral blood stem cell morbiliztion, a prospective, randomized, multicentric phase II clinical trial

Recombinant human thrombopoietin (rhTPO) combined with granulocyte colony stimulating factor (G-CSF) for autologous peripheral blood stem cell morbiliztion, a prospective, randomized, multicentric phase II clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17010787
Enrollment
Unknown
Registered
2017-03-05
Start date
2010-12-31
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

lymphoma for Autologous peripheral blood stem

Interventions

Experimental group:With TPO
Control Group:Without TPO

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as lymphoma with pathological evidences; 2. Patients that have indications for APBSCT and are willing to have transplantation; 3. Aged 18-60 years; 4. ECOG =3 5. Normal organ functions should satisfy: liver function: ALT, AST, TBIL= twice of the normal maximum; renal function: BUN, Cr=1.5 times of the normal maximum; cardiac function: ECG reveals no signs of acute myocardial infarction, arrhythmia, nor II or III degree of a-v blockage; heart function failure should be no more than degree II; no active rheumatic heart diseases; 6. No contraindications for chemotherapy; 7. Patients should sign the written consent before enrollment of the trial, and the written consent should consent all the contents of the trial; 8. Willing to follow the therapeutic plan, the follow-up plan and take the corresponding lab examinations.

Exclusion criteria

Exclusion criteria: 1. Contra-indications for chemotherapy; 2. Patients with severe organ impairment: including respiratory failure, heart failure of degree II and beyond, decompensated liver failure, renal failure; uncontrolled hypertention or diabetes, severe diabetic retinal disease; 3. Use of cytokines beside G-CSF within 3 weeks prior to enrollment; 4. Uncontrolled infection; 5. History of severe rhTPO allergy; 6. Women during pregnancy or lactation; 7. Patients that are participating other trials; 8. Patients with other severe acute/chronic physical or mental disorders, or with abnormal lab tests that may impair drug administration or influence the researchers evaluation, or influence the explanation about the results.

Design outcomes

Primary

MeasureTime frame
nucleated cell count;CD34+ cell count;times needed for collecting required amount of cells;

Secondary

MeasureTime frame
compliance rate;excellence rate;implantation time;RBC transfusion amount after implantation;Platelet transfusion amount after implantation;Incidence of infection during transplantation;

Countries

China

Contacts

Public ContactChun Wang

Shanghai General Hospital

wangchunmd@163.com+86 13386259777

Outcome results

None listed

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