A Phase 2 interventional study of Sodium Copper Chlorophyllin in Oral Mucositis, Total Body Irradiation and Hematological Malignancies, sponsored by Tata Memorial Centre. Recruiting at 1 site in India. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Tata Memorial Centre · Phase 2, Interventional, and Supportive care
The goal of this phase II, single-arm interventional clinical trial is to evaluate whether oral sodium copper chlorophyllin (CHL) can reduce the frequency and severity of oral mucositis in patients aged 12-65 years undergoing myeloablative total body irradiation (TBI) as part of conditioning before their first allogeneic Hematopoietic Stem Cell Transplantation (HSCT).
The main questions it aims to answer are:
Does oral chlorophyllin reduce the incidence of Grade III and IV oral mucositis by day +28 after HSCT? Does oral chlorophyllin reduce the duration of severe oral mucositis and the need for total parenteral nutrition (TPN), opioid analgesics, and other treatment-related toxicities, while maintaining acceptable safety?
Participants will:
Receive oral sodium copper chlorophyllin 750 mg once daily (tablet or oral suspension) starting 48 hours before TBI conditioning and continuing until day +28 after HSCT.
Undergo standard myeloablative TBI-based conditioning and allogeneic Hematopoietic Stem Cell Transplantation (HSCT) as part of routine clinical care.
Have regular clinical assessments for oral mucositis, treatment-related toxicities, engraftment, and graft-versus-host disease (GVHD).
Provide blood and saliva samples at predefined time points for cytokine and pharmacokinetic analyses.
Total body irradiation (TBI)-based myeloablative conditioning is an established component of allogeneic hematopoietic stem cell transplantation (HSCT) for patients with Hematologic Malignancies, particularly acute leukemias. Although effective, TBI is associated with significant acute toxicities, among which oral mucositis is one of the most common and debilitating complications. Severe (Grade III-IV) oral mucositis can result in severe pain, inability to eat, increased opioid analgesic use, total parenteral nutrition (TPN), prolonged hospitalization, and increased risk of infection. Published studies have reported a 44-71% incidence of severe oral mucositis following TBI-based conditioning, while institutional data demonstrate an incidence of approximately 70%.
Currently, there is no widely available standard prophylactic therapy for preventing radiation-induced oral mucositis in patients undergoing TBI-based conditioning. Palifermin has shown benefit in selected transplant populations but has limited evidence in TBI recipients, is costly, and is not readily available in India. Therefore, there is a need for a safe, affordable, and effective preventive strategy.
Sodium copper chlorophyllin (CHL) is a phytopharmaceutical derived from chlorophyll with antioxidant, anti-inflammatory, immunomodulatory, and radioprotective properties. Preclinical studies have demonstrated that CHL scavenges radiation-induced free radicals, reduces radiation-related tissue injury, promotes hematopoietic recovery, and protects normal tissues without protecting malignant cells or compromising the graft-versus-leukemia effect. A completed Phase I clinical study in healthy volunteers demonstrated that oral CHL is safe and well tolerated.
This prospective, single-center, single-arm Phase II study will evaluate the efficacy and safety of oral CHL in reducing severe oral mucositis in patients undergoing myeloablative TBI prior to first allogeneic HSCT. Eligible participants aged 12-65 years will receive oral CHL 750 mg once daily (tablet or oral suspension) beginning 48 hours before initiation of TBI conditioning and continuing until day +28 after transplantation, in addition to standard conditioning and transplant care.
The primary endpoint is the incidence of Grade III-IV oral mucositis by day +28 following HSCT. Secondary endpoints include the duration of severe oral mucositis, incidence and duration of TPN and opioid analgesic use, incidence of Grade III-IV nausea, vomiting and diarrhea, time to neutrophil and platelet engraftment, cumulative incidence of acute graft-versus-host disease (GVHD) by day 100, and non-relapse mortality. Exploratory objectives include evaluation of inflammatory cytokine profiles and the pharmacokinetic profile of CHL.
The findings from this study will provide preliminary evidence regarding the effectiveness of chlorophyllin as an inexpensive and well-tolerated radioprotective agent for reducing oral mucositis in patients undergoing TBI-based conditioning for allogeneic HSCT and will inform the design of future randomized clinical trials.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 17 is below the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Tata Memorial Centre is the lead sponsor of 64 studies on the registry; 42 are open to participants now.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive oral sodium copper chlorophyllin (CHL) 750 mg once daily (tablet or oral suspension) beginning 48 hours before initiation of myeloablative total body irradiation (TBI) conditioning (Day -9) and continuing until Day +28 after allogeneic hematopoietic stem cell transplantation (HSCT). All participants will receive standard TBI-based conditioning and HSCT as part of routine clinical care. The study will evaluate the efficacy and safety of CHL in reducing the incidence and severity of oral mucositis.
Drug: Sodium Copper Chlorophyllin
Sodium copper chlorophyllin (CHL) will be administered orally at a dose of 750 mg once daily (tablet or oral suspension) on an empty stomach, starting 48 hours before initiation of myeloablative total body irradiation (TBI) conditioning and continued until Day +28 after allogeneic hematopoietic stem cell transplantation (HSCT). The study drug is administered as an adjunct to standard TBI-based conditioning to evaluate its efficacy in reducing the incidence and severity of oral mucositis.
Also known as: CHL, Chlorophyllin
Incidence of Grade III-IV Oral Mucositis
The incidence of Grade III-IV oral mucositis will be assessed using the WHO Oral Mucositis Grading Scale (Grade 0: No oral mucositis.Grade 1: Erythema (redness) and soreness.Grade 2: Ulcers are present, but the patient is still able to tolerate solid foods.Grade 3: Extensive ulcers requiring the patient to switch to a liquid diet.Grade 4: Severe ulceration, making all oral alimentation (eating and drinking) impossible) in participants receiving oral sodium copper chlorophyllin during myeloablative total body irradiation (TBI)-based conditioning prior to allogeneic hematopoietic stem cell transplantation (HSCT).
Time frame: From initiation of conditioning until Day +28 after HSCT.
Duration of Grade III-IV Oral Mucositis
Duration of Grade III-IV oral mucositis, measured as the number of days participants experience severe oral mucositis based on the WHO Oral Mucositis Grading Scale (Grade 0: No oral mucositis.Grade 1: Erythema (redness) and soreness.Grade 2: Ulcers are present, but the patient is still able to tolerate solid foods.Grade 3: Extensive ulcers requiring the patient to switch to a liquid diet.Grade 4: Severe ulceration, making all oral alimentation (eating and drinking) impossible)
Time frame: Day 0 to Day +28 after HSCT
Incidence of Total Parenteral Nutrition (TPN) Use
Proportion of participants requiring total parenteral nutrition during the study period.
Time frame: Day 0 to Day +28 after HSCT
Duration of Total Parenteral Nutrition (TPN)
Duration of total parenteral nutrition use, measured as the number of days participants require TPN.
Time frame: Day 0 to Day +28 after HSCT
Incidence of Opioid Analgesic Use
Proportion of participants requiring opioid analgesics for pain management.
Time frame: Day 0 to Day +28 after HSCT
Duration of Opioid Analgesic Use
Number of days participants receive opioid analgesics
Time frame: Day 0 to Day +28 after HSCT
Time to Neutrophil and Platelet Engraftment
Time from transplantation to neutrophil and platelet engraftment, measured in days.
Time frame: Up to Day +28 after HSCT
Incidence of Grade III-IV Diarrhea
Incidence of Grade III-IV diarrhea assessed according to CTCAE Version 5.0.
Time frame: Day 0 to Day +28 after HSCT
Non-Relapse Mortality (NRM)
Death from any cause other than disease relapse or refractory disease.
Time frame: 100 days after allogeneic HSCT
Cumulative Incidence of Grade III-IV Acute Graft-versus-Host Disease (GVHD)
Cumulative incidence of Grade III-IV acute GVHD assessed using the Glucksberg grading system
Time frame: 100 days after allogeneic HSCT
Plan to share: No — Participant confidentiality and privacy will be protected in accordance with institutional policies, applicable regulations, and informed consent. Only de-identified aggregate study results will be reported in scientific publications and presentations.
Started Oct 2024 (actual). Primary completion is estimated for Mar 2027, 28 months after the start.
Of 39 phase 2 interventional studies under Stomatitis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's planned 28 months is below that.
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Studies of the drug tested here: Chlorophyllin
Tata Memorial Centre